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.

Survival of human cadaver skin on severe combined immune deficiency pigs: Proof of concept.

Transplantation of human xenografts onto immunocompromised mice is a powerful research tool for studying wound healing. However, differences in healing between humans and mice and their small size limit this model. We determined whether human cadaver skin xenografts transplanted onto pigs with severe combined immune deficiency (SCID) would survive and not be rejected. Meshed (1:1.5), cryopreserved human cadaver skin was transplanted onto 10 partial thickness dermatome wounds in each of two normal domestic pigs and two SCID pigs. Autografts (n = 2/animal) from the four animals were used as controls. In normal pigs, all autografts were engrafted and healed with a minimal, if any, inflammation and scarring. All human xenografts were rejected by the normal pigs within 5-11 days and associated with an intense T-cell inflammatory response. In contrast, both autografts and xenografts were engrafted and survived the 28-day study in the SCID pigs with a minimal inflammation and no gross scarring.

The effects of platelet rich plasma on healing of full thickness burns in swine.

INTRODUCTION: Platelet rich plasma (PRP) is rich in growth factors and has been shown to improve healing in a variety of wounds. We determined the effects of PRP on healing and scarring in full thickness porcine burns with and without tangential excision and grafting (TEG). METHODS: Standardized full thickness 5cm by 5cm burns were created on each of the backs and flanks of 10 anesthetized female pigs (25kg) using a validated model. The burns were created with a heating device that emits heat at a temperature of 400°C for a period of 30s. The burns were randomized to one of six treatments: no TEG or PRP, no TEG+PRP, early (day 2) TEG and no PRP, early TEG+PRP, late (day 14) TEG and no PRP, and late TEG+PRP. Tangential excision was performed down to viable tissue and autografts were 0.2mm thick. When used, a thin layer of autologous PRP was applied below the graft. All wounds were then treated with a topical antibiotic ointment 3 times weekly for 42 days. Digital images and full thickness biopsies were taken at 9, 11, 14, 18, 21, 28, 35 and 42days after injury to determine percentage reepithelialization, scar depth, and scar contraction. Tissue sections were stained with H&E and viewed by a dermatopathologist masked to treatment assignment. RESULTS: There was no reduction in platelet and white blood cell concentrations in PRP and blood samples for the first 14days after-full thickness burns. A total of 120 burns were created on 10 animals evenly distributed between the six treatment groups. Burns undergoing early TEG reepithelialized fastest and with the thinnest scars followed by late TEG. Burns that did not undergo TEG had the slowest reepithelialization and greatest amount of scarring. Application of PRP had no additional effects on reepithelialization, scar depth, or scar contraction in any of the treatment groups. CONCLUSIONS: Addition of PRP had similar effects on reepithelialization and scarring of full thickness porcine burns as standard topical antibiotic ointment regardless of whether the burns underwent excision or grafting or the timing of excision and grafting.

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.

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.

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.

Bone Healing Promotion by Negatively Charged Polysterene Microspheres.

Bone healing under optimal conditions is fairly predictable. Yet when the healing process is disturbed by inadequate immobilization, inadequate blood supply, or scar tissue, little therapeutic alternatives to surgery exist.It appears that redistribution of electric charges along the bone during a callus consolidation promotes bone healing. It has been shown in the past that negatively charged polysterene spheres promote bone growth in animal models.In this preliminary report, we tested weather or not a commercial device of negatively charged polysterene spheres promotes bone healing in a porcine model.This preliminary study seems to suggest that the negatively charged polystyrene microspheres may have a potential in promoting bone healing, either alone or as an adjunct to other bone graft materials. These speculations should be further validated by large-scale studies in animal models and clinical trials.

[DEMOGRAPHIC AND ANATOMIC CHARACTERISTICS AND SURGERY RESULTS IN CHILDREN WHO WERE TREATED IN SOROKA FOR CRANIOSYNOSTOSIS].

BACKGROUND: Craniosynostosis, the premature fusion of one or more of the cranial sutures, can occur as a part of a syndrome or as an isolated deformity. When not treated properly it may have major physical and social implications. STUDY HYPOTHESIS: We assumed that our center's results are similar to those reported in the literature, in terms of gender and anatomic characteristics, and different in terms of the number of syndromic cases. We also assume that only a few patients needed a second surgery and that this medical problem effects quality of life in term of cognitive impairment and aesthetic results. METHODS: A retrospective chart review was conducted of patients who were treated for craniosynostosis in Soroka University Medical Center between the years 1991-2005. RESULTS: A total of 63 patients were treated in Soroka during those years: 30 (47.6%) were females and 33 (50.8%) were males; 27 (42.9%) had coronal synostosis, 20 (31.8%) had sagital synostosis, 10 (15.8%) had metopic synostosis, 5 (7.9%) had lambdoid synostosis. A total of 5 (7.9%) cases were syndromic and the rest were isolated; 6 patients (9.5%) needed a second surgery for correction of the defect; 8 out of 30 patients (26.7%) 6 years or older at the present time suffer from attention deficit disorder. Parents' satisfaction from aesthetic results on a scale of 1-5 was 4.77 with SD of 0.504, while the doctors' score was 3.93 with SD 0.980 (p = 0.01). CONCLUSIONS: Craniosynostosis is a complex surgical problem, however with prompt treatment it may attain high levels of satisfaction among parents and patients. We found high rates 26.7% vs 10% (in the general population) of ADD in children affected by the disease.

[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.

Early versus Delayed Excision and Grafting of Full-Thickness Burns in a Porcine Model: A Randomized Study.

BACKGROUND: The standard of care for full-thickness burns is tangential excision followed by skin autografting; however, the timing of excision and grafting is subject to debate. The authors compared early (2 days) versus delayed (14 days) excision and grafting in a porcine full-thickness burn model. METHODS: Full-thickness burns (n = 12) were created on the backs of two anesthetized pigs and assigned randomly to no excision, tangential excision followed by skin autografting 2 days after injury, or tangential excision followed by skin autografting 14 days after injury. Digital images and full-thickness biopsy specimens were taken at 16, 21, 28, and 42 days after injury to determine percentage reepithelialization and scar depth. RESULTS: At day 16, all burns that were excised early were completely reepithelialized, whereas only eight of 11 nonexcised burns (72.7 percent) were reepithelialized (p = 0.02). By day 21, all burns were completely reepithelialized. Scar thickness was greatest at 42 days in nonexcised burns (7.5 ± 2.1 mm); scars were thinner after early excision than after late excision (2.2 ± 1.8 mm versus 4.0 ± 1.1 mm; p < 0.001, analysis of variance). Wounds treated with early or late tangential excision followed by skin autografting were flat and minimally contracted, whereas all nonexcised burns were red, contracted, and slightly raised. Scar contraction at 28 and 42 days was greatest in nonexcised control wounds compared with early and late excised wounds. CONCLUSIONS: Both early and late excision followed by autografting reduce scarring in a full-thickness porcine burn model. However, early excision (2 days after injury) reduces scar thickness to a greater extent than later (after 14 days) excision.

Static laser speckle contrast analysis for noninvasive burn diagnosis using a camera-phone imager.

Laser speckle contrast analysis (LASCA) is an established optical technique for accurate widefield visualization of relative blood perfusion when no or minimal scattering from static tissue elements is present, as demonstrated, for example, in LASCA imaging of the exposed cortex. However, when LASCA is applied to diagnosis of burn wounds, light is backscattered from both moving blood and static burn scatterers, and thus the spatial speckle contrast includes both perfusion and nonperfusion components and cannot be straightforwardly associated to blood flow. We extract from speckle contrast images of burn wounds the nonperfusion (static) component and discover that it conveys useful information on the ratio of static-to-dynamic scattering composition of the wound, enabling identification of burns of different depth in a porcine model in vivo within the first 48 h postburn. Our findings suggest that relative changes in the static-to-dynamic scattering composition of burns can dominate relative changes in blood flow for burns of different severity. Unlike conventional LASCA systems that employ scientific or industrial-grade cameras, our LASCA system is realized here using a camera phone, showing the potential to enable LASCA-based burn diagnosis with a simple imager.

Aplasia cutis congenita: clinical management and a new classification system.

BACKGROUND: Aplasia cutis congenita is a rare, congenital disorder. In its severe phenotype, it is potentially life threatening. Its management and the timing of surgery remain controversial because of the risks involved with both conservative and surgical approaches. Most literature is based on case reports and very small case series because of the rarity of the disorder. The authors present their experience treating newborns with aplasia cutis congenita and its progressive development. METHODS: Using a hospital registry, the authors found all cases of newborns diagnosed with aplasia cutis congenita during the years 2000 to 2013. Clinical data were gathered from hospital and clinic records, and photographs were obtained by the plastic surgery team. RESULTS: Twenty-two cases of aplasia cutis congenita were included in this study: 21 on the scalp and one on the foot heel. Eleven patients were male and 11 were female. Defect size ranged from 1 to 150 cm (average, 29 cm). Three patients died as a result of uncontrollable hemorrhage. Six patients underwent emergency coverage, one with allografts later replaced by split-thickness skin grafts and five by immediate split-thickness skin grafting. All of the patients who underwent immediate skin grafting survived and thrived. CONCLUSIONS: The authors emphasize the role of emergency split-thickness skin grafting in the treatment of large aplasia cutis congenita or ones with large veins or sagittal sinus exposure. The authors also present a practical, treatment-oriented classification that could assist physicians in estimating the severity and therefore prognosis of the disease and offer a treatment guideline. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

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.

Objective estimates of the risk factors for death and length of hospitalization following burn injuries, Soroka University Medical Center, 2001-2002.

BACKGROUND: Burn injuries are extremely common and may impose a serious load on public health around the world. OBJECTIVES: To compare mortality rates and length of hospitalization according to the identified risk factors, extent of burn, gender and age. METHODS: In this retrospective study, data from 558 archive files of hospitalization due to burns as the diagnosis in patients of all ages, between the years 2001 and 2002, were analyzed to identify the risk factors for mortality and length of hospitalization. RESULTS: Males comprised 62.4% of the hospitalized burn patients. The mortality rate was 3.2% (n = 18) and among them 55.6% were women. Fifty percent of the fatality cases were over 48 years old, with statistically significant correlation of mortality rate and age. Most of the fatality cases (66.7%) had burns with total burn surface area (TBSA) larger than 40%. The multiple logistic regression model showed that leukocyte count on admission, TBSA, and age are the most important predictors of mortality. Smoke inhalation was not found to be an independent risk factor. CONCLUSIONS: Using a statistical model for estimating the mortality rate, this study found that white blood cell count at admission, TBSA, and age were the most significant predictors of mortality.

Immediate burn excision fails to reduce injury progression.

The contact thermal injury model in the pig was used to determine whether immediate burn excision could alter the extent of injury progression. It was hypothesized that immediate excision of burns would prevent or reduce tissue necrosis in the uninjured interspaces. Four comb burns were created on the back of each animal, using a brass comb preheated in hot water (100 °C) for 5 minutes. This brass comb produced four distinctive burns sites separated by three "interspaces" of unburned skin, which were to undergo progressive injury. Immediately after burn creation, half of the full-thickness burns were excised leaving the unburned interspaces intact. Two full-thickness excisional wounds per pig with the dimensions identical to the comb burns were included as controls. Burn injury progression was microscopically assessed and reported as the percentage of unburned interspaces that progressed to full-thickness necrosis 7 days after injury. Scar formation was grossly evaluated on day 28 after injury and reported as the total surface area (in square centimeters) of the scar. A total of 24 combs with 72 interspaces were evenly distributed among the three groups. The unburned interspaces of both comb burns and excised comb burns had undergone progressive injury and were 100% dead (24/24; i.e., necrotic and/or apoptotic) 7 days postinjury (95% confidence interval, 86-100%) for both. However, interspaces of the control excisional wounds maintained complete viability, that is, no necrosis or apoptosis (0/24 [0%]; 95% confidence interval, 0-14%; P < .001). There was no significant difference in both surface area and depth of scar resulting from excised and nonexcised comb burns. Immediate burn excision neither prevented nor limited burn injury progression.

Epidemiology of cleft lip and palate among Jews and Bedouins in the Negev.

BACKGROUND: Clefts of the lip and palate are the most common significant congenital birth anomaly of the orofacial region. The condition may vary from a minor easily correctable cleft to a significant functional and cosmetic incapacitation. This is the first epidemiological study of orofacial clefts in the Negev region in Israel. OBJECTIVES: To establish the frequency of cleft lip and palate in the population of the Negev, characterize the demographic features of affected individuals and find possible risk factors, compare the risk in two major population groups: Bedouin and Jewish in a well-defined geographic area, and determine whether there is a change overtime in the birth of babies with facial clefts. METHODS: We conducted a retrospective survey of the Soroka Medical Center archives. The sample population comprised all 131,218 babies born at Soroka during the 11 year period 1 January 1996 to 31 December 2006. Statistical tests used Pearson's chi-square test, Student's t-test and Spearman's correlation coefficient test according to the type of parameter tested. RESULTS: During the study period 140 babies were born with orofacial cleft. The overall incidence of cleft lip and palate was 1.067/1000. The incidence of facial clefts was 1.54/1000 among Bedouins and 0.48/1000 among Jews (P < 0.001). Cleft palate was significantly more frequent in female than male babies (P = 0.002). Over the study years we found a significant decrease in the incidence of facial clefts in the Bedouin population, with Spearman's correlation coefficient rank -0.9 (P < 0.01). CONCLUSIONS: A significant decrease occurred in the incidence of facial clefts among Bedouin. This change may be attributed to prenatal care in the Bedouin Negev population as part of social and health-related behavior changes. The reduction in rates of congenital malformations, however, does not mean a reduction in the number of cases in a growing population. Also, with a modern western lifestyle, the expectancy and demand for reconstructive facial surgery and comprehensive care for these children are on the rise.