Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial.

Since 1970 surgeons have managed deep burns by surgical debridement and autografting. We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as standard of care (SOC). In this Phase 3 trial, we randomly assigned adults with deep burns (covering 3-30% of total body surface area [TBSA]) to NexoBrid, surgical or nonsurgical SOC, or placebo Gel Vehicle (GV) in a 3:3:1 ratio. The primary endpoint was complete eschar removal (ER) at the end of the debridement phase. Secondary outcomes were need for surgery, time to complete ER, and blood loss. Safety endpoints included wound closure and 12 and 24-months cosmesis on the Modified Vancouver Scar Scale. Patients were randomized to NexoBrid (n = 75), SOC (n = 75), and GV (n = 25). Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs 72%; P < .001). Median time to ER was 1.0 and 3.8 days for the NexoBrid and SOC respectively (P < .001). ER blood loss was lower in the NexoBrid than the SOC group (14 ± 512 mL vs 814 ± 1020 mL, respectively; P < .0001). MVSS scores at 12 and 24 months were noninferior in the NexoBrid versus SOC groups (3.7 ± 2.1 vs 5.0 ± 3.1 for the 12 months and 3.04 ± 2.2 vs 3.30 ± 2.76 for the 24 months). NexoBrid resulted in early complete ER in >90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.

An open-label, proof-of-concept study assessing the effects of bromelain-based enzymatic debridement on biofilm and microbial loads in patients with venous leg ulcers and diabetic foot ulcers.

BACKGROUND: Most chronic wounds contain biofilm, and debridement remains the centerpiece of treatment. Enzymatic debridement is an effective tool in removing nonviable tissue, however, there is little evidence supporting its effect on planktonic and biofilm bacteria. OBJECTIVE: This study evaluated the effects of a novel BBD agent on removal of nonviable tissue, biofilm, and microbial loads in patients with chronic ulcers. MATERIALS AND METHODS: Twelve patients with DFU or VLU were treated with up to 8 once-daily applications of BBD and then followed for an additional 2 weeks. Punch biopsy specimens were collected and analyzed for biofilm, and fluorescence imaging was used to measure bacterial load. RESULTS: Ten patients completed treatment, and 7 achieved complete debridement within a median of 2 applications (range, 2-8). By the end of the 2-week follow-up period, the mean ± SD reduction in wound area was 35% ± 38. In all 6 patients who were positive for biofilm at baseline, the biofilm was reduced to single individual or no detected microorganisms by the end of treatment. Red fluorescence for Staphylococcus aureus decreased from a mean of 1.09 cm² ± 0.58 before treatment to 0.39 cm² ± 0.25 after treatment. BBD was safe and well tolerated. CONCLUSION: Preliminary data suggest that BBD is safe and that it can be used to effectively debride DFU and VLU, reduce biofilm and planktonic bacterial load, and promote reduction in wound size.

Rapid enzymatic burn debridement: A review of the paediatric clinical trial experience.

NexoBrid (NXB) has been proven to be an effective selective enzymatic debridement agent in adults. This manuscript presents the combined clinical trial experience with NXB in children. Hundred and ten children aged 0.5 to 18 years suffering from deep thermal burns of up to 67% total body surface area were treated with NXB in three clinical trials. Seventy-seven children were treated with NXB in a phase I/II study, where 92.7% of the areas treated achieved complete eschar removal within 0.9 days from admission. Thirty-three children (17 NXB, 16 standard of care [SOC]) participated in a phase III randomized controlled trial. All wounds treated with NXB achieved complete eschar removal. Time to complete eschar removal (from informed consent) was 0.9 days for NXB vs 6.5 days for SOC (P < .001). The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001). Seventeen of these children participated in a phase III-b follow-up study (9 NXB and 8 SOC). The average long-term modified Vancouver Scar Scale scores were 3.4 for NXB-treated wounds vs 4.4 for SOC-treated wounds (NS). There were no significant treatment-related adverse events. Additional studies are needed to strengthen these results.

Development of a contaminated ischemic porcine wound model and the evaluation of bromelain based enzymatic debridement.

OBJECTIVES: There are no well accepted animal models of chronic wounds, limiting advances in understanding and treatment of chronic ulcers. We developed a porcine wound model which combines multiple factors involved in chronic wounds to create a contaminated necrotic eschar and evaluated the debriding efficacy of a novel bromelain based enzymatic debriding agent (EscharEx). METHODS: Contaminated ischemic wounds were created on the flanks of domestic pigs by 'sandwiching' the skin between 2 'O' rings (1 placed on the surface of the skin and the other underneath the skin) for 24h prior to dermatomal excision of the necrotic eschar and its contamination with Staphylococcus aureus and Candida albicans. After confirming the development of infected eschars, additional animals were used to compare the effects of daily application of topical EscharEx or its hydrating vehicle on eschar debridement as a control. RESULTS: In all cases, application of the 'O' rings resulted in full thickness necrotic ecshars with invasive infections, which did not reepithelialize and sloughed off spontaneously within 14-21 days. All wounds reepithelialized within 28-42 days forming contracted scars. All EscharEx treated eschars were completely debrided within 7-9 days, while no debridement was evident in eschars treated with the control gel. CONCLUSIONS: Our model simulates the initial phase of chronic wounds characterized by a contaminated necrotic eschar allowing evaluation of wound debriding agents, and that a bromelain-based debriding agent completely debrides the contaminated necrotic eschars within one week in this model.

Bromelain-based enzymatic debridement of chronic wounds: A preliminary report.

Sharp debridement is currently considered most effective for debridement of chronic wounds; however, some patients do not have access to or cannot be treated by surgical methods. This study was designed to provide a first impression of the safety and efficacy of bromelain-based enzymatic debridement of chronic wounds. Two consecutive single-arm studies assessing the enzymatic debridement efficacy of a concentrate of proteolytic enzymes enriched in bromelain in chronic wounds was conducted in 2 medical centres. Patients were treated with up to 11 consecutive 4-hour enzymatic debridement sessions and then treated until wound closure. Twenty-four patients with chronic wounds of different aetiologies were enrolled. All wounds achieved an average of 68% ± 30% debridement in an average of 3.5 ± 2.8 enzymatic debridement 4-hour sessions. Seventeen responding wounds (venous, diabetic, pressure, and post-traumatic aetiologies) achieved an average 85% ± 12% debridement in 3.2 ± 2.5 applications. Seven non-responding wounds (arterial and post-surgical aetiologies) achieved an average 26% ± 13% debridement in 4.3 ± 3.5 applications. No treatment-related serious adverse events were observed, and the only adverse event attributed to the enzymatic debridement was pain. These preliminary results indicate the potential safety and efficacy of bromelain-based enzymatic debridement in chronic wounds. Larger controlled studies are needed to further investigate this indication.

Enzymatic Versus Traditional Surgical Debridement of Severely Burned Hands: A Comparison of Selectivity, Efficacy, Healing Time, and Three-Month Scar Quality.

Severe burns of the hands are extremely challenging, given their anatomic complexity and vulnerability. Although excisional debridement with autografting remains the standard of care (SOC), previous studies have shown that use of enzymatic debridement with bromelain (NexoBrid, EDNX) enables rapid, selective enzymatic debridement, preserving viable tissue. To date, only two studies accruing data on EDNX in this setting have been published. The current study was conducted to compare EDNX with traditional surgical debridement (TSD) of deep dermal and full-thickness hand burns. This single-center, controlled clinical trial included 40 patients, aged 18 to 76 years, with deep dermal burns of the hand. The first 20 patients were debrided surgically, and the other 20 patients were using EDNX for debridement. Therapeutic selectivity, time to complete debridement and healing, complications, and 3-month functional/esthetic outcomes were compared by group. EDNX (vs TSD) significantly reduced time to complete debridement after admission (0.95 day vs 7.750 days; P < .001) and treatments needed for complete debridement (1.05 vs 1.45; P < .001), improving burn depth evaluation (initially overestimated in 55% of EDNX-treated patients). The number of wounds requiring autografting was certainly reduced (15% vs 95%; P = .034), as was time to complete healing after first debridement (23.30 vs 32.00 days; P < .001), and early scar quality after 3 months was nearly equivalent, with only heightened local redness in the EDNX group (P < .001). Compared with TSD, EDNX was superior in burn depth evaluation, tissue preservation, completeness of debridement, and wound closure. Scar quality after 3 months did not differ substantially.

Enzymatic debridement of deeply burned faces: Healing and early scarring based on tissue preservation compared to traditional surgical debridement.

INTRODUCTION: Facial burns occur frequently and depending on the injured skin layers often heal with scars which may cause permanent functional and cosmetic sequelae. Preservation of the sensitive facial skin layers, especially of the dermis is essential for scarless epithelialisation. Enzymatic debridement of deep thermal burns has already been shown to assist with preserving viable dermis. However, up to date, there are no published reports on wound healing and in the long term aesthetic outcome after enzymatic debridement of facial burns. METHODS: Therefore we performed a-single centre clinical trial that included 26 subjects aged 18-78 years with facial burns clinically evaluated as deep dermal or deeper. Burns were treated either with enzymatic debridement or excisional surgical debridement. Then we compared both groups regarding debridement selectivity, wound closure and scar quality after more than 12 months. RESULTS: Enzymatic debridement significantly reduced time to complete wound closure after admission (19.85 days versus 42.23 days, p=0.002), and after enzymatic eschar removal (18.92 days versus 35.62 days, p=0.042). The number of procedures to complete debridement were significantly lower in the enzymatic debridement group (1.00 versus 1.77, p=0.003). 77% of facial burns that had been debrided enzymatically were found to be more superficially burned than initially estimated. Wounds undergoing autografting of any size were significantly reduced by enzymatic debridement (15% versus 77%, p=0.002). Scar quality after enzymatic debridement was superior compared to surgical debridement after 12 months regarding pigmentation (p=0.016), thickness (p=0.16), relief (p=0.10), pliability (p=0.01), surface area (p=0.004), stiffness (p=0.023), thickness (0.011) and scar irregularity (p=0.011). Regarding erythema and melanin, viscoelasticity and pliability, trans-epidermal water loss or laser tissue oxygen saturation, haemoglobin level and microcirculation we found no significant differences for treated and untreated skin in the EDNX group. CONCLUSION: In our current study we found Bromelain based enzymatic debridement better in some aspects of tissue preservation in deep dermal facial burn.

[REVIEW OF 30 YEARS OF RESEARCH AND DEVELOPMENT OF AN ENZYMATIC DEBRIDEMENT AGENT FOR BURNS].

INTRODUCTION: Early removal of burn eschar is a cornerstone of burn care. The most commonly practiced eschar removal technique for deep burns in modern burn care is surgical debridement but this technique is associated with surgical burden and leads to unnecessary excision of viable tissue. GOALS: To review 30 years of research and development of an enzymatic debridement agent for burns. METHODS: Studies performed during the last 30 years are reviewed in this manuscript. RESULTS: Patients who underwent enzymatic debridement had a significantly shorter time to complete debridement, the surgical burden was significantly lower, hand burns did not necessitate escharotomy, and the long term results were favorable. DISCUSSION: Early enzymatic debridement leads to an efficient debridement, preservation of viable tissue, a reduction in surgical burden and favorable long term results. CONCLUSION: We believe early enzymatic debridement will lead to better care for burn victims and perhaps, even to a paradigm shift in the treatment of burns.

A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT.

OBJECTIVES: Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, non-surgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC. METHODS: We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4h) or SOC, which included surgical excisional or non-surgical debridement. RESULTS: NXB significantly reduced the time from injury to complete débridement (2.2 vs. 8.7 days, P<0.0001), need for surgery (24.5% vs. 70.0%, P<0.0001), the area of burns excised (13.1% vs. 56.7%, P<0.0001) and the need for autografting (17.9% vs. 34.1%, P=0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events. CONCLUSIONS: Enzymatic débridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns. TRIAL REGISTRATION: Clinical Trials.gov NCT00324311.

Selectivity of a bromelain based enzymatic debridement agent: a porcine study.

BACKGROUND: Debridement of the burn eschar is a cornerstone of burn wound care. Rapid enzymatic debridement with a bromelain-based agent (Debriding Gel Dressing-DGD) has recently been investigated. The current study was designed to further investigate the selectivity of DGD to burned eschar in a larger number and more varied types of wounds. METHODS: A systematic animal experiment was conducted to determine the effects of DGD on normal, non-injured skin, burns, exposed dermis of donor sites, and skin punch biopsy wells. Partial thickness dermal burns and partial thickness skin graft donor sites were created on a pig and treated with a 4-h application of DGD or its control hydrating vehicle that does not have any activity except hydration. Punch biopsy samples were taken before and after treatment and microscopically assessed for evidence of tissue viability and its respective components thickness. RESULTS: Rapid dissolution of the burn eschar was noted in all DGD but not vehicle treated burns. There was no apparent damage to the underlying sub eschar dermis, donor sites, normal skin or punch biopsy wells after exposure to DGD. While the thickness of the treated tissues slightly increased due to edema, the increase in dermal thickness was similar after treatment with DGD or its vehicle. The increase in the cross section surface area of the treated punch biopsy wells was similar after treatment with DGD and its control vehicle. CONCLUSIONS: Exposure of the burn eschar to DGD results in its rapid dissolution. Exposure of normal skin or non-burned dermis to DGD has no effects demonstrating its selectivity to eschar.

Comparison of purified olive oil and silver sulfadiazine in the treatment of partial thickness porcine burns.

INTRODUCTION: Burns are widespread in the developed world, and expensive burn dressings are not universally available. Most burn patients suffer from a partial thickness burn that can be treated conservatively. Nevertheless, the ideal dressing for the burn wound has not been identified. We performed an animal experiment to compare the healing of partial thickness burns treated with silver sulfadiazine (SSD) and olive oil. METHODS: A randomized controlled animal experiment was conducted on 3 anesthetized domestic pigs in which 51 partial thickness burns were created using a metal bar heated to 400°C and applied to the dorsum of the animals for 20 seconds. The burns were treated every other day with SSD cream (n = 16), purified olive oil (n = 20), or no topical therapy at all (n = 15). Assessment of wound healing was done by drawing and scanning the margins of the wound at the endpoint of the experiment. The remaining open wound area was then calculated using Scion Image version beta 4.0.2 (Scion, Frederick, Md), and the results were analyzed using a 1-way ANOVA test. RESULTS: Burns treated with SSD healed faster than control burns (P < .05). There were no differences in the healing rates of wounds treated with olive oil versus controls or SSD. There were no wound infections in any of the 3 study groups. CONCLUSIONS: Treatment of partial thickness burns with purified olive oil did not result in faster healing when compared with SSD or dry gauze in a porcine model.

Efficacy of enzymatic debridement of deeply burned hands.

BACKGROUND: The burned hand is a common and difficult to care-for entity in the field of burns. Due to the anatomy of the hand (important and delicate structures crowded in a small limited space without sub-dermal soft tissue), surgical debridement of the burned tissue is technically difficult and may cause considerable complications and, therefore, should be performed judiciously. Selective enzymatic debridement of the burn wound can preserve the spontaneous epithelialisation potential and reduce the added injury to the traumatised tissue added by a surgical debridement. OBJECTIVE: The aim of the study was to assess the implication of a selective enzymatic compound (Debrase(®) - Ds) in the special field of deep hand burns, by comparing the actual burn area that required surgical coverage after enzymatic debridement to the burn area clinically judged to require skin grafting prior to debridement. MATERIALS AND METHODS: This was a retrospective data collection and analysis from 154 complete files of prospective, open-label study in 275 hospitalised, Ds-treated burn patients. RESULTS: A total of 69 hand burns diagnosed as 'deep' was analysed; 36% of the wounds required surgical intervention after enzymatic debridement; 28.6% of the total burned area estimated initially as deep was covered by skin graft (statistically significant p<0.001). CONCLUSION: Debridement of deep-hand burns with a selective enzymatic agent decreased the perceived full-thickness wound area and skin-graft use.

Reepithelialization of mid-dermal porcine burns after rapid enzymatic debridement with Debrase®.

Reepithelialization of mid-dermal burns is delayed by the presence of a layer of necrotic eschar. The authors hypothesized that rapid selective debridement using an enzymatic bromelain-based preparation, Debrase®, would speed reepithelialization. Forty mid-dermal burns (2.5 × 2.5 cm) were created on the back and flanks of two anesthetized domestic pigs (25 kg) using an aluminum bar (150 g) preheated in hot water (80°C) and applied for 20 seconds. The burns were randomized to a 4-hour topical application of Debrase® (n = 20) or its vehicle (n = 20) followed by daily application of a petrolatum-based triple antibiotic. Wounds were visualized and photographed daily for evidence of reepithelialization. Reepithelialization was considered complete when the entire wound was opaque and dry when blotted with tissue paper. 4-mm full-thickness biopsies were obtained for histological analysis using hematoxylin and eosin staining by a board-certified dermatopathologist masked to the burn therapy at 7, 9, 11, and 13 days after injury. The primary outcome was time to complete reepithelialization of the burns. Secondary outcomes were the percentage of burns that were reepithelialized at days 7, 11, and 13 and the mean percentage reepithelialization on microscopic analysis. A sample of 20 burns in each group had 80% power to detect a 2-day difference in the time to complete reepithelialization (two-tailed, P < .05). Application of Debrase®, but not the control vehicle, resulted in dissolution of the necrotic upper dermis in all treated burns. The mean time to complete reepithelialization was faster for Debrase®-treated (7.4 ± 0.8 days) than control-treated (9.1 ± 2.1 days) burns: difference, 1.7 days (95% confidence interval, 0.5-2.9). The percentage of completely reepithelialized Debrase®- and control-treated burns were day 7, 65.0 vs 25.0% (P = .02); day 9, 80.0 vs 40.0% (P = .02); and day 11, 100.0 vs 92.0% (P = .45). Treatment of mid-dermal porcine burns with a single topical application of Debrase® results in earlier wound reepithelialization.

The effects of rapid enzymatic debridement of deep partial-thickness burns with Debrase on wound reepithelialization in swine.

Reepithelialization of deep burns requires spontaneous or active removal or debridement of the necrotic eschar, as recently defined by the American Burn Association. Debrase is a bromelain-derived enzymatic preparation that has been shown to result in rapid and selective debridement of human and animal burns. The authors hypothesized that rapid debridement of deep dermal burns with Debrase would result in earlier reepithelialization of the remaining dermis in a porcine model. Eighty deep dermal contact burns measuring 10 by 20 mm were created on the back and flanks of anesthetized domestic pigs (25 kg) using a brass template preheated in boiling water (100 degrees C) that was applied to the skin for a period of 30 seconds. The template was applied using a spring-loaded device designed to control the amount of pressure applied to the skin by the template. Burns were randomized to a 4-hour topical application of Debrase (lyophilized dry enzyme dissolved and activated in a hydrating vehicle) (n = 40) or its hydrating vehicle (n = 40) followed by daily application of a petrolatum-based antibiotic ointment. Wounds were visually assessed and photographed daily. Four-millimeter full-thickness punch biopsies were obtained for histological analysis using hematoxylin and eosin staining by a board-certified dermatopathologist masked to burn therapy at 7, 11, 13, and 15 days after injury. The primary outcome was the percentage of the burns that were completely reepithelialized at each time point. Secondary outcomes were time to complete reepithelialization and the mean percentage of reepithelialization on microscopic analysis. A sample of 40 burns in each group had 80% power to detect a 20% difference in the percentage of completely reepithelialized burns (two tailed, P < .05). The percentage of completely reepithelialized burns was higher for Debrase than control burns at days 11 (40.9% vs 3.1%; P = .002), 13 (87.5% vs 50%; P = .007), and 15 (97.5% vs 77.5%, P = .018). The mean (SD) percentage reepithelialization of Debrase-treated burns at 7 days was higher than of control burns (47.6% [3.2] vs 0% [0]; P < .001). A larger number of cells in the epidermis and dermis of debrided burns stained positive for the proliferation antigen Ki-67. There was no evidence of any adverse events in the normal skin adjacent to the Debrase-treated burns. Rapid enzymatic debridement of deep partial-thickness burns with Debrase results in earlier reepithelialization and cellular proliferation in swine, when compared with carrier and topical antibiotic dressings alone.

Rapid and selective enzymatic debridement of porcine comb burns with bromelain-derived Debrase: acute-phase preservation of noninjured tissue and zone of stasis.

Deep burns are associated with the formation of an eschar, which delays healing and increases the risk of infection. Surgical debridement of the eschar is, at present, the fastest means to achieve an eschar-free bed, but the process can not differentiate between the viable tissue and the eschar and follow the minute irregularities of the interface between the two. We evaluated the efficacy and selectivity of a novel enzymatic bromelain-based debriding agent, Debrase Gel Dressing (Debrase), in a porcine comb burn model. We hypothesized that Debrase would result in rapid debridement of the eschar without adverse effects on the surrounding uninjured skin. This is a prospective, controlled, animal experiment. Five domestic pigs (20-25 kg) were used in this study. Sixteen burns were created on each animal's dorsum using a brass comb with four rectangular prongs preheated in boiling water and applied for 30 seconds, resulting in four rectangular 10 x 20 mm full-thickness burns and separated by three 5 x 20 mm unburned interspaces representing the zone of stasis. The burned keratin layer (blisters) was removed, and the burns were treated with a single, topical, Debrase or control vehicle application for 4 hours. The Debrase/control was then wiped off using a metal forceps handle, and the burns were treated with a topical silver sulfadiazine (SSD). The wounds were observed, and full-thickness biopsies were obtained at 4 and 48 hours for evidence of dermal thickness, vascular thrombosis, and burn depth, both within the comb burns and the unburned interspaces in between them. Chi-square and t tests are used for data analysis. A single 4-hour topical application of Debrase resulted in rapid and complete eschar dissolution of all the burns in which the keratin layer was removed. The remaining dermis was thinner (1.1 +/- 0.7 mm) than in the control burns (2.1 +/- 0.3 mm; difference 0.9 mm [95% confidence interval: 0.3-1.4]) and was viable with no injury to the normal surrounding skin or to the unburned interspaces between the burns, which represents the zone of stasis. In control burns, the entire thickness of the dermis was necrotic. At 48 hours, Debrase-treated areas were found partially desiccated under SSD treatment. The unburned interspaces demonstrated partial-thickness necrosis in two third and full-thickness necrosis in one third of wounds. In contrast, full-thickness necrosis was noted in all control interspaces (P = .05). In a porcine comb burn model, a single, 4-hour topical application of Debrase resulted in rapid removal of the necrotic layer of the dermis with preservation of unburned tissues. At 48 hours, SSD treatment resulted in superficial tissue damage and partial preservation of the unburned interspaces.

Combined ultrasonic and enzymatic debridement of necrotic eschars in an animal model.

Several methods are used to debride burn eschars, however, most are ineffective for ischemic eschars. We investigated a novel combination of enzymatic and ultrasonic debridement for ischemic eschars. A previously described ischemic flap model in rats was used to compare the time to flap debridement or perforation of enzymatic (Debrase, a derivative of bromelain), ultrasonic, or combined debridement (Hybrid Debridement Technology). We also evaluated the effects of ultrasonic intensity, probe size, probe housing, and operation mode (pulsatile vs. continuous) on the time to full eschar perforation. Ultrasonic and enzymatic debridement alone did not result in flap perforation even after 15 minutes. Combined ultrasonic and enzymatic debridement resulted in flap perforation within 2 to 5 minutes in the four flap zones (P < 0.001 for all four flap zones compared with ultrasound alone). The most rapid debridement was observed with an ultrasonic intensity of 3.2 W/cm, applied using a 4.9 cm probe. The temperature elevation associated with ultrasonication was controlled by perfusion of fresh Debrase solution and alternating the ultrasound energy. Combination of ultrasonic and enzymatic debridement of ischemic flap eschars in rats with Debrase is more rapid and effective than either method alone.

The effect of Lactobacillus bacteria supplement on sepsis and its complications in patients with acute burns.

Sepsis as a result of bacterial translocation from the gastrointestinal tract (GIT) is a known associate of morbidity and mortality in patients with severe burns. This translocation is influenced by the GIT flora. Oral consumption of Lactobacillus bacteria was previously shown to reduce translocation. We conducted a retrospective cohort study on a series of 56 patients with burns admitted to Soroka University Medical Center in Beer-Sheva, Israel. Those 56 patients included 28 who were given lactobacillus supplements and 28 who were not. The parameters that were compared between the groups evaluated the level of sepsis and its complications. The parameters of morbidity during hospitalization were significantly higher in the treatment group; however, their mortality was lower. That difference in mortality between the groups was not significant as a whole (p=0.071), but it was significant in the subgroup analysis of 41-70% total body surface area burned. In that subgroup there were zero cases of death in the treatment group versus five cases in the control group (p=0.005). Our findings suggest that in acute burns, lactobacillus bacteria food additives may be clinically beneficial in patients with total burned body surface area of 41-70%.

Escharotomy using an enzymatic debridement agent for treating experimental burn-induced compartment syndrome in an animal model.

BACKGROUND: In patients with deep circumferential burns, adequate resolution of burn-induced compartment syndrome (BICS) is achieved by surgical escharotomy. Surgical escharotomy is traumatic, may cause considerable blood loss, does nothing toward debridement of the burn wound, and entails possible morbidity and complications. Debridase is a Bromelain derived enzymatic preparation capable of lysing the burn eschar within 4 hours, obviating the need for surgical debridement. It has an affinity to burned necrotic tissue and does not damage healthy skin. In our clinical assessment of the Debridase efficacy, we found in several cases of deep burns of the limbs that the measured IC pressure subsided after 2-4 hours of Debridase application and none of the enzymatic escharotomy treated patients suffering from circumferential burns developed BICS. To confirm these observations we conducted this controlled study. AIM: to assess the efficacy of Debridase for treating BICS in an animal model. MATERIALS AND METHODS: A model for BICS was developed by making circumferential burns to pig legs and monitoring the anterior compartment the legs. BICS was induced in the legs of 5 pigs, 20 legs. 10 legs were treated with Debridase and 10 served as nontreated controls, treated by surgical escharotomy at the conclusion of the experiment. RESULTS: Debridase reduced BICS within 30 minutes from application. Debridase was as effective as a standard surgical escharotomy. CONCLUSION: Escharectomy using an effective enzymatic debriding agent is potentially an adequate, simple, fast and effective procedure to treat BICS, it has the added benefit of burn debridement without surgical escharotomy.

Safety and efficacy of a proteolytic enzyme for enzymatic burn debridement: a preliminary report.

A prospective, non-comparative study design was used to describe our experience with a bromelain-derived debriding agent, Debridase, in 130 patients with 332 deep second degree and third degree burns treated between 1984 and 1999. Debridase was applied after saturating the burns with a moist dressing for 2-24h. Debridase was applied for a period of 4h under an occlusive dressing. Mean patient age was 18.6 +/- 19.3, 42 (32.3%) were female, and 63 (48.5%) were children under age 18. Most burns were small. Debridase was applied once in 241 (72.6%) of the 332 wounds, twice in 67 (20.18%) cases, three times in 12 (3.61%) cases, and four times in 2 (0.6%) cases. The percentage debridement by number of applications was 89 +/- 21% for a single application, 77 +/- 27% for two, and 62 +/- 27% for three Debridase applications, respectively. There were no significant adverse events. The availability of a fast acting, reliable and complication-free enzymatic debriding agent may open new horizons and provide a new treatment modality for burns.