Aesthetic Dermatology

SALT LAKE CITY — The Pressure Ulcer Scale for Healing proved superior to assessment by experienced nurses in determining status and progression of long-term care residents' wounds, researchers reported at the annual symposium of the American Medical Directors Association.

"It was surprising because we thought the clinical way was the better way," said Dr. Erica George-Saintilus with Long Island Jewish Medical Center, who presented a poster on her study at the center-affiliated Cold Spring Hills Center for Nursing and Rehabilitation in Woodbury, N.Y.

Whereas nurses assessed the wounds primarily by subjective impressions and wound size, the Pressure Ulcer Scale for Healing (PUSH) tool tallied three parameters:

▸ Wound size in scores representing skin area from none (0) to more than 24 cm

▸ Amount of exudate from none (0) to heavy (3).

▸ Tissue type from closed/resurfaced (0) to necrotic tissue/eschar (4).

The team reviewed records of all residents with stage II-IV ulcers in the 627-bed skilled nursing facility from 2004 through 2006. Weekly reports on the wounds included data sufficient to calculate a PUSH score as well as nurse assessments such as "improved," "deteriorated," or "unchanged." In patients with multiple wounds, the study tracked only one ulcer.

"There's no indication [from statistical analyses] that nurses' observations agree at all with the PUSH," said Dr. George-Saintilus.

Looking specifically at 2 months of data for 30 residents, the researchers determined that PUSH scores were better than the nurses' assessments at indicating the direction that a wound was taking. Dr. George-Saintilus pointed out instances in which a pressure ulcer that a nurse had recorded as "healed" returned and got worse. In contrast, PUSH scores were more likely to indicate the true progression of a wound.

Further, Dr. George-Saintilus and her colleagues discovered that the nurses' assessments were idiosyncratic. "Each nurse has her own way of giving her impression," the researcher said.

PUSH was introduced 11 years ago by the National Pressure Ulcer Advisory Panel, a coalition of corporate and professional organizations that sets care standards. AMDA's "Pressure Ulcers in the Long-Term Care Setting" clinical practice guideline cites PUSH as a "validated tool for characterizing and monitoring pressure ulcers." The guideline includes directions and a blank scoring sheet, and the advisory panel offers the same at http://www.npuap.org/PDF/push3.pdf

Dr. George-Saintilus said that her observations of nurses at the Cold Spring Hills facility, which now uses the PUSH tool, show that PUSH is actually quicker to use than the subjective system. The old record keeping included nurses' assessments and several wound parameters but didn't combine those data into a score that could be tracked as easily as the PUSH score. She said that PUSH "saves time and money."

SALT LAKE CITY — The Pressure Ulcer Scale for Healing proved superior to assessment by experienced nurses in determining status and progression of long-term care residents' wounds, researchers reported at the annual symposium of the American Medical Directors Association.

"It was surprising because we thought the clinical way was the better way," said Dr. Erica George-Saintilus with Long Island Jewish Medical Center, who presented a poster on her study at the center-affiliated Cold Spring Hills Center for Nursing and Rehabilitation in Woodbury, N.Y.

Whereas nurses assessed the wounds primarily by subjective impressions and wound size, the Pressure Ulcer Scale for Healing (PUSH) tool tallied three parameters:

▸ Wound size in scores representing skin area from none (0) to more than 24 cm

▸ Amount of exudate from none (0) to heavy (3).

▸ Tissue type from closed/resurfaced (0) to necrotic tissue/eschar (4).

The team reviewed records of all residents with stage II-IV ulcers in the 627-bed skilled nursing facility from 2004 through 2006. Weekly reports on the wounds included data sufficient to calculate a PUSH score as well as nurse assessments such as "improved," "deteriorated," or "unchanged." In patients with multiple wounds, the study tracked only one ulcer.

"There's no indication [from statistical analyses] that nurses' observations agree at all with the PUSH," said Dr. George-Saintilus.

Looking specifically at 2 months of data for 30 residents, the researchers determined that PUSH scores were better than the nurses' assessments at indicating the direction that a wound was taking. Dr. George-Saintilus pointed out instances in which a pressure ulcer that a nurse had recorded as "healed" returned and got worse. In contrast, PUSH scores were more likely to indicate the true progression of a wound.

Further, Dr. George-Saintilus and her colleagues discovered that the nurses' assessments were idiosyncratic. "Each nurse has her own way of giving her impression," the researcher said.

PUSH was introduced 11 years ago by the National Pressure Ulcer Advisory Panel, a coalition of corporate and professional organizations that sets care standards. AMDA's "Pressure Ulcers in the Long-Term Care Setting" clinical practice guideline cites PUSH as a "validated tool for characterizing and monitoring pressure ulcers." The guideline includes directions and a blank scoring sheet, and the advisory panel offers the same at http://www.npuap.org/PDF/push3.pdf

Dr. George-Saintilus said that her observations of nurses at the Cold Spring Hills facility, which now uses the PUSH tool, show that PUSH is actually quicker to use than the subjective system. The old record keeping included nurses' assessments and several wound parameters but didn't combine those data into a score that could be tracked as easily as the PUSH score. She said that PUSH "saves time and money."

SALT LAKE CITY — The Pressure Ulcer Scale for Healing proved superior to assessment by experienced nurses in determining status and progression of long-term care residents' wounds, researchers reported at the annual symposium of the American Medical Directors Association.

"It was surprising because we thought the clinical way was the better way," said Dr. Erica George-Saintilus with Long Island Jewish Medical Center, who presented a poster on her study at the center-affiliated Cold Spring Hills Center for Nursing and Rehabilitation in Woodbury, N.Y.

Whereas nurses assessed the wounds primarily by subjective impressions and wound size, the Pressure Ulcer Scale for Healing (PUSH) tool tallied three parameters:

▸ Wound size in scores representing skin area from none (0) to more than 24 cm

▸ Amount of exudate from none (0) to heavy (3).

▸ Tissue type from closed/resurfaced (0) to necrotic tissue/eschar (4).

The team reviewed records of all residents with stage II-IV ulcers in the 627-bed skilled nursing facility from 2004 through 2006. Weekly reports on the wounds included data sufficient to calculate a PUSH score as well as nurse assessments such as "improved," "deteriorated," or "unchanged." In patients with multiple wounds, the study tracked only one ulcer.

"There's no indication [from statistical analyses] that nurses' observations agree at all with the PUSH," said Dr. George-Saintilus.

Looking specifically at 2 months of data for 30 residents, the researchers determined that PUSH scores were better than the nurses' assessments at indicating the direction that a wound was taking. Dr. George-Saintilus pointed out instances in which a pressure ulcer that a nurse had recorded as "healed" returned and got worse. In contrast, PUSH scores were more likely to indicate the true progression of a wound.

Further, Dr. George-Saintilus and her colleagues discovered that the nurses' assessments were idiosyncratic. "Each nurse has her own way of giving her impression," the researcher said.

PUSH was introduced 11 years ago by the National Pressure Ulcer Advisory Panel, a coalition of corporate and professional organizations that sets care standards. AMDA's "Pressure Ulcers in the Long-Term Care Setting" clinical practice guideline cites PUSH as a "validated tool for characterizing and monitoring pressure ulcers." The guideline includes directions and a blank scoring sheet, and the advisory panel offers the same at http://www.npuap.org/PDF/push3.pdf

Dr. George-Saintilus said that her observations of nurses at the Cold Spring Hills facility, which now uses the PUSH tool, show that PUSH is actually quicker to use than the subjective system. The old record keeping included nurses' assessments and several wound parameters but didn't combine those data into a score that could be tracked as easily as the PUSH score. She said that PUSH "saves time and money."

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

CINCINNATI — Control of blood glucose levels through intensive insulin therapy has been shown to reduce morbidity in both surgical and medical ICU patients, as well as mortality in surgical ICU patients. Results of a retrospective study now suggest that implementation of this therapy in burn patients may reduce the rate of infectious complications but not mortality.

Maintaining mean blood glucose levels of less than 140 mg/dL reduced the rate of pneumonia, ventilator-associated pneumonia, and urinary tract infections in 71 burn patients who received intensive insulin therapy, compared with 81 burn patients in the same ICU during the year before the protocol was implemented, Dr. Mark R. Hemmila reported at the annual meeting of the Central Surgical Association.

But some discussants at the meeting questioned whether certain weaknesses in the study's design and differences in patient characteristics may have contributed to its results.

During the first year of an intensive insulin therapy protocol (July 2005 to June 2006), Dr. Hemmila and his colleagues at the University of Michigan, Ann Arbor, sought to bring burn patients' blood glucose levels to less than 140 mg/dL. In the previous year (July 2004 to June 2005), burn patients had received an insulin drip protocol when their blood glucose levels exceeded 150 mg/dL.

The patients in each group had a mean age in the early 40s, and close to three-fourths in each group were men. The investigators excluded patients with concomitant trauma and burn injuries or desquamating skin diseases.

The control and intensive insulin therapy groups had similar blood glucose levels upon admission (142 mg/dL vs. 130 mg/dL, respectively) and in terms of daily average (135 mg/dL vs. 129 mg/dL) as well as overall mean during their hospital stay (127 mg/dL vs. 126 mg/dL). The intensive insulin-treated and control groups each spent a similar percentage of time in the hospital with a mean daily blood glucose level greater than 140 mg/dL (22% vs. 35%, respectively). But compared with patients in the control group, those who were treated with intensive insulin therapy spent a significantly lower percentage of their time in the hospital with a maximum mean daily blood glucose level greater than 200 mg/dL (11% vs. 17%).

In multivariate analyses that adjusted for age, gender, the percentage of total body surface area burned, and inhalation injury, adding intensive insulin therapy did not significantly improve the outcomes obtained in burn patients in the year before the therapy was implemented. There were no improvements in mortality (7% vs. 9%, respectively, among intensive insulin vs. control patients), mean length of stay in the ICU (5 vs. 9 days), mean length of stay in the hospital overall (10 vs. 17 days), and mean number of days requiring ventilation (3 vs. 6 days).

However, intensive insulin therapy significantly reduced rates of pneumonia overall (16% vs. 37%), ventilator-associated pneumonia (10% vs. 31%), and urinary tract infection (6% vs. 22%).

The odds of developing infection were more than 11 times higher in patients with a maximum mean glucose of greater than 140 mg/dL than in those with a maximum blood glucose level of 140 mg/dL or less. Of patients with maximum blood glucose levels higher than 140 mg/dL, 61 had an infection and 32 did not, whereas those with blood glucose levels of 140 mg/dL comprised 6 with infection and 53 without. Based on these values, a maximum blood glucose level greater than 140 mg/dL predicted the development of infectious complications, Dr. Hemmila said.

"Measurement of a blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection in patients with burn injury," he concluded.

Dr. Peter J. Fabri of the University of South Florida, Tampa, a discussant at the meeting, noted a recent study suggesting that the complication rate of tight blood glucose control may actually negate its benefits (N. Engl. J. Med. 2008;358:125–39). "We have to be very careful being critical when we look at these studies," Dr. Fabri said. "It's very rare that one thing is the only thing that changes in a busy, successful critical care unit over a 2-year period of time."

'A blood glucose level greater than 140 mg/dL should heighten the clinical suspicion for presence of an infection.' DR. HEMMILA

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

SAN DIEGO — Treatment of stage II pressure ulcers with a self-adhesive polyurethane foam dressing was more cost effective than was treatment with standard saline-soaked gauze, according to a multicenter, randomized trial.

"The current wound care practice in the United States is still dominated by the traditional methods such as saline-soaked gauze or wet-to-dry gauze," Dr. Wyatt G. Payne said in a poster presented at the annual meeting of the Wound Healing Society.

"Many facilities still use this low-technology, low-cost dressing treatment because many practitioners are not fully convinced that advanced wound care products provide fully the benefits they claim, and as such do not warrant the increased costs per dressing. The increased cost per dressing of advanced wound care products leads to the perception that they are expensive, when they may actually be a more cost effective alternative because they need changing less often," he wrote.

Dr. Payne of the Bay Pines VA Healthcare System in St. Petersburg, Fla., and associates, randomized 36 patients with stage II pressure ulcers to receive Allevyn Thin self-adhesive polyurethane foam dressing (Smith & Nephew) or saline-soaked gauze. Each patient was assessed each week for 4 weeks, unless the ulcer closed.

Mean patient age was 73 years and more than half (61%) were men. The mean cost of dressing and other materials for patients in the polyurethane foam dressing group was $32 per week, compared with $58 per week for those in the saline-soaked gauze group. "This implies that a switch from gauze to polyurethane foam would make it possible to treat 80% more patients with the same materials budget," the researchers estimated.

Overall mean treatment cost per week was also lower for patients in the foam-dressing group, $91, compared with a mean of $209 for the saline-soaked gauze group. The savings of $118 per patient "is consistent with a saving in the cost on nursing time of $92 per week," Dr. Payne reported at the meeting, which was held in conjunction with a symposium on advanced wound care.

"This represents more than 3 hours of nursing time per patient per week (assuming a median wage of $28 per hour for a registered nurse)," he wrote.

Dressings were changed a mean of five times per week in the foam-dressing group, compared with a mean of 13 times per week in the saline-soaked gauze group. At the end of 4 weeks, 50% of the wounds in the foam-dressing group were closed, compared with 38% of those in the saline-soaked gauze group, but there was no evidence of a difference between the two groups in time to wound closure.

Total per patient costs over the 4-week evaluation period ranged from $265 to $315 in the foam-dressing group and from $691 to $781 in the saline-soaked gauze group. The number of days free of ulcer was 9 vs. 7, respectively.

Smith & Nephew funded the study. Dr. Payne said that he has no financial interest in the company.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment of stage II pressure ulcers with a self-adhesive polyurethane foam dressing was more cost effective than was treatment with standard saline-soaked gauze, according to a multicenter, randomized trial.

"The current wound care practice in the United States is still dominated by the traditional methods such as saline-soaked gauze or wet-to-dry gauze," Dr. Wyatt G. Payne said in a poster presented at the annual meeting of the Wound Healing Society.

"Many facilities still use this low-technology, low-cost dressing treatment because many practitioners are not fully convinced that advanced wound care products provide fully the benefits they claim, and as such do not warrant the increased costs per dressing. The increased cost per dressing of advanced wound care products leads to the perception that they are expensive, when they may actually be a more cost effective alternative because they need changing less often," he wrote.

Dr. Payne of the Bay Pines VA Healthcare System in St. Petersburg, Fla., and associates, randomized 36 patients with stage II pressure ulcers to receive Allevyn Thin self-adhesive polyurethane foam dressing (Smith & Nephew) or saline-soaked gauze. Each patient was assessed each week for 4 weeks, unless the ulcer closed.

Mean patient age was 73 years and more than half (61%) were men. The mean cost of dressing and other materials for patients in the polyurethane foam dressing group was $32 per week, compared with $58 per week for those in the saline-soaked gauze group. "This implies that a switch from gauze to polyurethane foam would make it possible to treat 80% more patients with the same materials budget," the researchers estimated.

Overall mean treatment cost per week was also lower for patients in the foam-dressing group, $91, compared with a mean of $209 for the saline-soaked gauze group. The savings of $118 per patient "is consistent with a saving in the cost on nursing time of $92 per week," Dr. Payne reported at the meeting, which was held in conjunction with a symposium on advanced wound care.

"This represents more than 3 hours of nursing time per patient per week (assuming a median wage of $28 per hour for a registered nurse)," he wrote.

Dressings were changed a mean of five times per week in the foam-dressing group, compared with a mean of 13 times per week in the saline-soaked gauze group. At the end of 4 weeks, 50% of the wounds in the foam-dressing group were closed, compared with 38% of those in the saline-soaked gauze group, but there was no evidence of a difference between the two groups in time to wound closure.

Total per patient costs over the 4-week evaluation period ranged from $265 to $315 in the foam-dressing group and from $691 to $781 in the saline-soaked gauze group. The number of days free of ulcer was 9 vs. 7, respectively.

Smith & Nephew funded the study. Dr. Payne said that he has no financial interest in the company.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Treatment of stage II pressure ulcers with a self-adhesive polyurethane foam dressing was more cost effective than was treatment with standard saline-soaked gauze, according to a multicenter, randomized trial.

"The current wound care practice in the United States is still dominated by the traditional methods such as saline-soaked gauze or wet-to-dry gauze," Dr. Wyatt G. Payne said in a poster presented at the annual meeting of the Wound Healing Society.

"Many facilities still use this low-technology, low-cost dressing treatment because many practitioners are not fully convinced that advanced wound care products provide fully the benefits they claim, and as such do not warrant the increased costs per dressing. The increased cost per dressing of advanced wound care products leads to the perception that they are expensive, when they may actually be a more cost effective alternative because they need changing less often," he wrote.

Dr. Payne of the Bay Pines VA Healthcare System in St. Petersburg, Fla., and associates, randomized 36 patients with stage II pressure ulcers to receive Allevyn Thin self-adhesive polyurethane foam dressing (Smith & Nephew) or saline-soaked gauze. Each patient was assessed each week for 4 weeks, unless the ulcer closed.

Mean patient age was 73 years and more than half (61%) were men. The mean cost of dressing and other materials for patients in the polyurethane foam dressing group was $32 per week, compared with $58 per week for those in the saline-soaked gauze group. "This implies that a switch from gauze to polyurethane foam would make it possible to treat 80% more patients with the same materials budget," the researchers estimated.

Overall mean treatment cost per week was also lower for patients in the foam-dressing group, $91, compared with a mean of $209 for the saline-soaked gauze group. The savings of $118 per patient "is consistent with a saving in the cost on nursing time of $92 per week," Dr. Payne reported at the meeting, which was held in conjunction with a symposium on advanced wound care.

"This represents more than 3 hours of nursing time per patient per week (assuming a median wage of $28 per hour for a registered nurse)," he wrote.

Dressings were changed a mean of five times per week in the foam-dressing group, compared with a mean of 13 times per week in the saline-soaked gauze group. At the end of 4 weeks, 50% of the wounds in the foam-dressing group were closed, compared with 38% of those in the saline-soaked gauze group, but there was no evidence of a difference between the two groups in time to wound closure.

Total per patient costs over the 4-week evaluation period ranged from $265 to $315 in the foam-dressing group and from $691 to $781 in the saline-soaked gauze group. The number of days free of ulcer was 9 vs. 7, respectively.

Smith & Nephew funded the study. Dr. Payne said that he has no financial interest in the company.

ELSEVIER GLOBAL MEDICAL NEWS

CORONADO, CALIF. — Two novel technologies are helping to control external bleeding when conventional methods such as direct pressure and gauze dressings fail.

These include products that contain chitosan or zeolite, Dr. Brant A. Putnam said at a meeting sponsored by the American College of Emergency Physicians.

Chitosan is a biodegradable, nontoxic carbohydrate derived from chitin, a naturally occurring substance. "It has a muco-adhesive property that binds everything together," said Dr. Putnam, chief of trauma and surgical care at Harbor-UCLA Medical Center in Torrance, Calif. "It probably activates platelets, and it may vasoconstrict locally. Then there are interactions with the red blood cell surface that we don't quite understand, so I'm sure there will be more research to follow."

Several animal studies have demonstrated its effectiveness as a hemostatic agent. In a human study published online Nov. 19, 2007, in the Journal of Emergency Medicine, paramedics used a hemostatic dressing made of chitosan (HemCon Bandage) in 34 wounds they couldn't control with direct pressure (doi:10.1016/j.jemermed.2007.05.043

The bandage, which was approved by the Food and Drug Administration in 2003 and requires users to cut it to the proper shape prior to application, controlled bleeding in 25 of the cases (74%) within 3 minutes. User error was a factor in six of the seven failures.

"You have to make sure that you put the right side down on the wound in order for the hemostasis to occur," Dr. Putnam explained.

The other technology proving effective for external hemostasis includes products that contain zeolite, a derivative of volcanic rock. When applied to gauze and placed on wounds, zeolite works as a molecular sieve and captures all the water locally, creating an exothermic reaction, said Dr. Putnam, who is also associate director of the Harbor-UCLA Medical Center general surgery residency program.

"We think that it dehydrates the wound of all the water properties, leaving a high concentration of all the clot-promoting components: the coagulation factors, the proteins, the cells," he explained.

The zeolite-based product QuikClot (Z-Medica Corp.), developed in 2002, is currently approved for external use only. But Dr. Putnam and his associates have used it on rare occasions to help pack life-threatening bleeding from internal wounds such as those caused by high-velocity gunfire. "I don't recommend that—I'm just saying that when we were faced with the life or death choice, we used it as part of packing internally, and the patients did very well," he said.

A recent survey of QuikClot's use in 69 cases by the U.S. military in Iraq, in 20 cases by civilian trauma surgeons, and in 14 cases by civilian first responders demonstrated an overall efficacy of 92% (J. Trauma 2008;64:1093–9). The researchers speculated that the QuikClot failures were due to the coagulopathic state of a patient from massive resuscitation or the inability to get the product directly to the source of bleeding.

Dr. Putnam said that he had no relevant disclosures to make.

CORONADO, CALIF. — Two novel technologies are helping to control external bleeding when conventional methods such as direct pressure and gauze dressings fail.

These include products that contain chitosan or zeolite, Dr. Brant A. Putnam said at a meeting sponsored by the American College of Emergency Physicians.

Chitosan is a biodegradable, nontoxic carbohydrate derived from chitin, a naturally occurring substance. "It has a muco-adhesive property that binds everything together," said Dr. Putnam, chief of trauma and surgical care at Harbor-UCLA Medical Center in Torrance, Calif. "It probably activates platelets, and it may vasoconstrict locally. Then there are interactions with the red blood cell surface that we don't quite understand, so I'm sure there will be more research to follow."

Several animal studies have demonstrated its effectiveness as a hemostatic agent. In a human study published online Nov. 19, 2007, in the Journal of Emergency Medicine, paramedics used a hemostatic dressing made of chitosan (HemCon Bandage) in 34 wounds they couldn't control with direct pressure (doi:10.1016/j.jemermed.2007.05.043

The bandage, which was approved by the Food and Drug Administration in 2003 and requires users to cut it to the proper shape prior to application, controlled bleeding in 25 of the cases (74%) within 3 minutes. User error was a factor in six of the seven failures.

"You have to make sure that you put the right side down on the wound in order for the hemostasis to occur," Dr. Putnam explained.

The other technology proving effective for external hemostasis includes products that contain zeolite, a derivative of volcanic rock. When applied to gauze and placed on wounds, zeolite works as a molecular sieve and captures all the water locally, creating an exothermic reaction, said Dr. Putnam, who is also associate director of the Harbor-UCLA Medical Center general surgery residency program.

"We think that it dehydrates the wound of all the water properties, leaving a high concentration of all the clot-promoting components: the coagulation factors, the proteins, the cells," he explained.

The zeolite-based product QuikClot (Z-Medica Corp.), developed in 2002, is currently approved for external use only. But Dr. Putnam and his associates have used it on rare occasions to help pack life-threatening bleeding from internal wounds such as those caused by high-velocity gunfire. "I don't recommend that—I'm just saying that when we were faced with the life or death choice, we used it as part of packing internally, and the patients did very well," he said.

A recent survey of QuikClot's use in 69 cases by the U.S. military in Iraq, in 20 cases by civilian trauma surgeons, and in 14 cases by civilian first responders demonstrated an overall efficacy of 92% (J. Trauma 2008;64:1093–9). The researchers speculated that the QuikClot failures were due to the coagulopathic state of a patient from massive resuscitation or the inability to get the product directly to the source of bleeding.

Dr. Putnam said that he had no relevant disclosures to make.

CORONADO, CALIF. — Two novel technologies are helping to control external bleeding when conventional methods such as direct pressure and gauze dressings fail.

These include products that contain chitosan or zeolite, Dr. Brant A. Putnam said at a meeting sponsored by the American College of Emergency Physicians.

Chitosan is a biodegradable, nontoxic carbohydrate derived from chitin, a naturally occurring substance. "It has a muco-adhesive property that binds everything together," said Dr. Putnam, chief of trauma and surgical care at Harbor-UCLA Medical Center in Torrance, Calif. "It probably activates platelets, and it may vasoconstrict locally. Then there are interactions with the red blood cell surface that we don't quite understand, so I'm sure there will be more research to follow."

Several animal studies have demonstrated its effectiveness as a hemostatic agent. In a human study published online Nov. 19, 2007, in the Journal of Emergency Medicine, paramedics used a hemostatic dressing made of chitosan (HemCon Bandage) in 34 wounds they couldn't control with direct pressure (doi:10.1016/j.jemermed.2007.05.043

The bandage, which was approved by the Food and Drug Administration in 2003 and requires users to cut it to the proper shape prior to application, controlled bleeding in 25 of the cases (74%) within 3 minutes. User error was a factor in six of the seven failures.

"You have to make sure that you put the right side down on the wound in order for the hemostasis to occur," Dr. Putnam explained.

The other technology proving effective for external hemostasis includes products that contain zeolite, a derivative of volcanic rock. When applied to gauze and placed on wounds, zeolite works as a molecular sieve and captures all the water locally, creating an exothermic reaction, said Dr. Putnam, who is also associate director of the Harbor-UCLA Medical Center general surgery residency program.

"We think that it dehydrates the wound of all the water properties, leaving a high concentration of all the clot-promoting components: the coagulation factors, the proteins, the cells," he explained.

The zeolite-based product QuikClot (Z-Medica Corp.), developed in 2002, is currently approved for external use only. But Dr. Putnam and his associates have used it on rare occasions to help pack life-threatening bleeding from internal wounds such as those caused by high-velocity gunfire. "I don't recommend that—I'm just saying that when we were faced with the life or death choice, we used it as part of packing internally, and the patients did very well," he said.

A recent survey of QuikClot's use in 69 cases by the U.S. military in Iraq, in 20 cases by civilian trauma surgeons, and in 14 cases by civilian first responders demonstrated an overall efficacy of 92% (J. Trauma 2008;64:1093–9). The researchers speculated that the QuikClot failures were due to the coagulopathic state of a patient from massive resuscitation or the inability to get the product directly to the source of bleeding.

Dr. Putnam said that he had no relevant disclosures to make.

SAN DIEGO — Use of Biobrane wound dressing in pediatric burn patients resulted in a short hospital stay and follow-up as an outpatient with few complications, results from a single-center study demonstrated.

Researchers reviewed the medical charts of 116 pediatric burn patients aged 0–18 years who received Biobrane wound dressing at the University Hospital trauma center in San Antonio, Tex., between 2002 and 2007.

Biobrane (Bertek Pharmaceuticals) is a synthetic nylon mesh that is bonded to silicone and coated with collagen peptides. It functions as an analogue to the dermis and its pores allow exudate to be drained. It has been shown to be a reasonable option in children, Dr. Cristiane M. Ueno said at the annual meeting of the Wound Healing Society.

The dressing "usually can be trimmed away after 1 week as the wound heals, decreasing the healing time when compared with some other dressings," Dr. Ueno of the University of Texas Health Science Center at San Antonio, said.

The average age of patients was 5 years, males outnumbered females 2:1, and more than two-thirds (68%) were Hispanic. Fifty-two percent of cases were scald injuries and 70% of the patients had second-degree burns.

Of the 116 patients who received Biobrane dressing, 58 had sustained burns to the upper extremity. More than two-thirds were admitted to the hospital for only 1–2 days for dressing care and instruction on care of the injury. Only seven complications occurred from the use of Biobrane, including one case of bacteremia, two cases of local infection, two cases of cellulitis, and two cases of fever, Dr. Ueno said at the meeting, held in conjunction with a symposium on advanced wound care.

The majority of patients needed only oral pain medications or mild conscious sedation, not general anesthesia, while undergoing debridement and Biobrane application and subsequent dressing changes. This, combined with the low risk of complications, suggests that the dressing could lower costs and reduce hospital stays in the pediatric burn population, said Dr. Ueno, who had no conflicts to disclose.

The child's burn is first cleaned with chlorhexidine and then bullae and nonviable tissue are removed (left). A Biobrane glove is then placed over the hand (right). Photos courtesy Dr. Cristiane M. Ueno

SAN DIEGO — Use of Biobrane wound dressing in pediatric burn patients resulted in a short hospital stay and follow-up as an outpatient with few complications, results from a single-center study demonstrated.

Researchers reviewed the medical charts of 116 pediatric burn patients aged 0–18 years who received Biobrane wound dressing at the University Hospital trauma center in San Antonio, Tex., between 2002 and 2007.

Biobrane (Bertek Pharmaceuticals) is a synthetic nylon mesh that is bonded to silicone and coated with collagen peptides. It functions as an analogue to the dermis and its pores allow exudate to be drained. It has been shown to be a reasonable option in children, Dr. Cristiane M. Ueno said at the annual meeting of the Wound Healing Society.

The dressing "usually can be trimmed away after 1 week as the wound heals, decreasing the healing time when compared with some other dressings," Dr. Ueno of the University of Texas Health Science Center at San Antonio, said.

The average age of patients was 5 years, males outnumbered females 2:1, and more than two-thirds (68%) were Hispanic. Fifty-two percent of cases were scald injuries and 70% of the patients had second-degree burns.

Of the 116 patients who received Biobrane dressing, 58 had sustained burns to the upper extremity. More than two-thirds were admitted to the hospital for only 1–2 days for dressing care and instruction on care of the injury. Only seven complications occurred from the use of Biobrane, including one case of bacteremia, two cases of local infection, two cases of cellulitis, and two cases of fever, Dr. Ueno said at the meeting, held in conjunction with a symposium on advanced wound care.

The majority of patients needed only oral pain medications or mild conscious sedation, not general anesthesia, while undergoing debridement and Biobrane application and subsequent dressing changes. This, combined with the low risk of complications, suggests that the dressing could lower costs and reduce hospital stays in the pediatric burn population, said Dr. Ueno, who had no conflicts to disclose.

The child's burn is first cleaned with chlorhexidine and then bullae and nonviable tissue are removed (left). A Biobrane glove is then placed over the hand (right). Photos courtesy Dr. Cristiane M. Ueno

SAN DIEGO — Use of Biobrane wound dressing in pediatric burn patients resulted in a short hospital stay and follow-up as an outpatient with few complications, results from a single-center study demonstrated.

Researchers reviewed the medical charts of 116 pediatric burn patients aged 0–18 years who received Biobrane wound dressing at the University Hospital trauma center in San Antonio, Tex., between 2002 and 2007.

Biobrane (Bertek Pharmaceuticals) is a synthetic nylon mesh that is bonded to silicone and coated with collagen peptides. It functions as an analogue to the dermis and its pores allow exudate to be drained. It has been shown to be a reasonable option in children, Dr. Cristiane M. Ueno said at the annual meeting of the Wound Healing Society.

The dressing "usually can be trimmed away after 1 week as the wound heals, decreasing the healing time when compared with some other dressings," Dr. Ueno of the University of Texas Health Science Center at San Antonio, said.

The average age of patients was 5 years, males outnumbered females 2:1, and more than two-thirds (68%) were Hispanic. Fifty-two percent of cases were scald injuries and 70% of the patients had second-degree burns.

Of the 116 patients who received Biobrane dressing, 58 had sustained burns to the upper extremity. More than two-thirds were admitted to the hospital for only 1–2 days for dressing care and instruction on care of the injury. Only seven complications occurred from the use of Biobrane, including one case of bacteremia, two cases of local infection, two cases of cellulitis, and two cases of fever, Dr. Ueno said at the meeting, held in conjunction with a symposium on advanced wound care.

The majority of patients needed only oral pain medications or mild conscious sedation, not general anesthesia, while undergoing debridement and Biobrane application and subsequent dressing changes. This, combined with the low risk of complications, suggests that the dressing could lower costs and reduce hospital stays in the pediatric burn population, said Dr. Ueno, who had no conflicts to disclose.

The child's burn is first cleaned with chlorhexidine and then bullae and nonviable tissue are removed (left). A Biobrane glove is then placed over the hand (right). Photos courtesy Dr. Cristiane M. Ueno

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.