Assessing the Effect of Enzymatic Debridement on the Scar Quality in Partial-Thickness Burns to Deep Dermal Burns of the Hand: A Long-Term Evaluation.

Background and Objectives: Burn surgery on the hands is a difficult procedure due to the complex anatomy and fragility of the area. Enzymatic debridement has been shown to effectively remove burn eschar while minimizing damage to the surrounding tissue and has therefore become a standard procedure in many burn centers worldwide over the past decade. However, surprisingly, our recent literature review showed limited valid data on the long-term scarring after the enzymatic debridement of the hands. Therefore, we decided to present our study on this topic to fill this gap. Materials and Methods: This study analyzed partial-thickness to deep dermal burns on the hands that had undergone enzymatic debridement at least 12 months prior. Objective measures, like flexibility, trans-epidermal water loss, erythema, pigmentation, and microcirculation, were recorded and compared intraindividually to the uninjured skin in the same area of the other hand to assess the regenerative potential of the skin after EDNX. The subjective scar quality was evaluated using the patient and observer scar assessment scale (POSAS), the Vancouver Scar Scale (VSS), and the "Disabilities of the Arm, Shoulder, and Hand" (DASH) questionnaire and compared interindividually to a control group of 15 patients who had received traditional surgical debridement for hand burns of the same depth. Results: Between January 2014 and December 2015, 31 hand burns in 28 male and 3 female patients were treated with enzymatic debridement. After 12 months, the treated wounds showed no significant differences compared to the untreated skin in terms of flexibility, trans-epidermal water loss, pigmentation, and skin surface. However, the treated wounds still exhibited significantly increased blood circulation and erythema compared to the untreated areas. In comparison to the control group who received traditional surgical debridement, scarring was rated as significantly superior. Conclusions: In summary, it can be concluded that the objective skin quality following enzymatic debridement is comparable to that of healthy skin after 12 months and subjectively fares better than that after tangential excision. This confirms the superiority of enzymatic debridement in the treatment of deep dermal burns of the hand and solidifies its position as the gold standard.

Implementing Nexobrid for Burn Debridement in a Major Italian Burn Center: A Retrospective Review of Patient Outcomes.

This retrospective study examines the implementation of Nexobrid, an enzymatic debriding agent developed from bromelain, for burn debridement in a major Italian burn center. With previous research showing encouraging results for Nexobrid in terms of reducing the need for surgical intervention and faster eschar removal, the current study aims to add to the growing body of evidence regarding its potential benefits and limitations. The patient database was utilized to identify patients who received Nexobrid treatment between October 2019 and June 2023. A retrospective analysis was conducted to gather demographic information, burn causes, procedural details, and patient outcomes. Of the 30 patients treated with Nexobrid, 10% did not require further surgical intervention, showcasing Nexobrid's potential to improve patient outcomes. However, over 80% of patients still required additional surgical intervention, demonstrating that Nexobrid's effectiveness varies across patients and should be considered a tool rather than a definitive solution in burn wound management. A few patients developed complications, and about 10% of patients succumbed to systemic complications. The study results reveal both the potential benefits and limitations of using Nexobrid in burn debridement. While it successfully eliminated the need for further surgical intervention in a small percentage of patients, the majority still required additional surgical procedures. These findings not only highlight Nexobrid's role as a tool in burn wound management but also point toward the discrepancies with previous studies. The authors suggest future research should include randomized controlled trials, direct comparisons between Nexobrid and traditional debridement methods, and studies incorporating larger and more diverse patient groups.

Does Enzymatic Debridement Allow Us To Perform Conservative Treatment On Clinically Deep Hand Burns? A Retrospective Review.

The hands are one of the main locations of burns. In deep second-degree and third-degree burns, the gold standard of treatment is surgical debridement and subsequent coverage, which can result in suboptimal aesthetic and functional results. The aim of our study is to assess whether treatment by initial enzymatic debridement (NexoBrid®) of deep second-degree and third-degree burns prevents the need for surgery. We carried out a retrospective study of 53 hands with deep burns treated in our centre from May 2015 to December 2016. Two experts evaluated the initial photographs of the burns and classified them as surgical or nonsurgical (interobserver kappa index = 0.83). These assessments were compared with the actual need for surgery on each hand. Sixteen of the 32 (50%) hands that the experts considered surgical spontaneously epithelialized. Four of the 17 hands (23.5%) that were not considered surgical required a split-thickness skin graft for healing. Enzymatic debridement helps to preserve viable tissue, which reduces the number and extension of surgical interventions, thus favouring better results.

Les mains sont une des principales localisations de brûlures. Dans les brûlures du 2e degré profond et du 3e degré, le traitement de référence est l'excision chirurgicale suivie d'un geste de couverture, et donne des résultats fonctionnels ou esthétiques pas toujours parfaits. Le but de notre étude est d'évaluer si le débridement enzymatique (NexoBrid®) des brûlures du 2e degré profond et du 3e degré permet d'éviter les gestes chirurgicaux. Nous avons mené une étude rétrospective sur 53 mains présentant des brûlures profondes traitées dans notre centre entre mai 2004 et décembre 2016. Deux experts ont évalué les photographies initiales et classé les brûlures en « chirurgicales ¼ ou « non chirurgicales ¼ (coefficient Kappa inter-opérateur = 0,83). Ces évaluations ont été comparées à la nécessité réelle de prise en charge chirurgicale pour chacune des mains. 16 des 32 mains (50%) que les experts avaient jugées « chirurgicales ¼ ont cicatrisé spontanément. 4 des 17 mains (23,5%) qui ont été considérée comme « non chirurgicales ¼ ont nécessité une greffe de peau mince pour obtenir la cicatrisation. Le débridement enzymatique permet de conserver les tissus viables, ce qui diminue le nombre et l'importance des gestes chirurgicaux, et donc favorise l'obtention de meilleurs résultats.

Eschar removal by bromelain based enzymatic debridement (Nexobrid®) in burns: European consensus guidelines update.

INTRODUCTION: Bromelain-based Enzymatic Debridement has been introduced as an additional concept to the burn surgeon's armamentarium and is best indicated for mid-to deep dermal burns with mixed patterns. Increasing evidence has been published focusing on special regions and settings as well as on limitations of Enzymatic Debridement to improve patient care. To better guide Enzymatic Debridement in view of the increasing experience, there is a need to update the formerly published consensus guidelines with user-orientated recommendations, which were last produced in 2017. METHODS: A multi-professional expert panel of plastic surgeons and burn care specialists from twelve European centers was convened, to assist in developing current recommendations for best practices with use of Enzymatic Debridement. Consensus statements were based on peer-reviewed publications and clinical relevance, and topics for re-evaluation and refinement were derived from the formerly published European guidelines. For consensus agreement, the methodology employed was an agreement algorithm based on a modification of the Willy and Stellar method. For this study on Enzymatic Debridement, consensus was considered when there was at least 80 % agreement to each statement. RESULTS: The updated consensus guidelines from 2019 refer to the clinical experience and practice patterns of 1232 summarized patient cases treated by the panelists with ED in Europe (2017: 500 cases), reflecting the impact of the published recommendations. Forty-three statements were formulated, addressing the following topics: indications, pain management and anesthesia, large surface treatment, timing of application for various indications, preparation and application, post-interventional wound management, skin grafting, outcome, scar and revision management, cost-effectiveness, patient´s perspective, logistic aspects and training strategies. The degree of consensus was remarkably high, with consensus in 42 out of 43 statements (97.7%). A classification with regard to timing of application for Enzymatic Debridement was introduced, discriminating immediate/very early (≤12 h), early (12-72 h) or delayed (>72 h) treatment. All further recommendations are addressed in the publication. CONCLUSIONS: The updated guidelines in this publication represent further refinement of the recommended indication, application and post-interventional management for the use of ED. The published statements contain detailed, user-orientated recommendations aiming to align current and future users and prevent pitfalls, e.g. for the successful implementation of ED in further countries like the USA. The significance of this work is reflected by the magnitude of patient experience behind it, larger than the total number of patients treated in all published ED clinical trials.

Eschar removal by bromelain based enzymatic debridement (Nexobrid®) in burns: An European consensus.

Early debridement and/or eschar removal is regarded as a significant step in the treatment of deep partial and full thickness burns. It aims to control wound bioburden and allows early wound closure by conservative treatment or skin grafting. Preservation of viable dermis accompanied by early wound closure, is regarded as a necessary step to reduce scar related complication, e.g. functional limitations and/or unaesthetic scar formation. Aside from the classical techniques of surgical excision as tangential excision for eschar removal, hydro-surgery, maggot therapy, laser, enzymatic debridement have been described as additional techniques in the burn surgeon's armamentarium. It is widely accepted that early eschar removal within 72h improves the outcome of burn wound treatment by reducing bacterial wound colonization, infection and length of hospital stay. In contrast, the right technique for eschar removal is still a matter of debate. There is increasing evidence that enzymatic debridement is a powerful tool to remove eschar in burn wounds, reducing blood loss, the need for autologous skin grafting and the number of wounds requiring surgical excision. In order to assess the role and clinical advantages of enzymatic debridement by a mixture of proteolytic enzymes enriched in Bromelain (Nexobrid®) beyond the scope of the literature and in view of users' experience, a European Consensus Meeting was scheduled. The aim was to provide statements for application, based on the mutual experience of applying enzymatic debridement in more than 500 adult and pediatric patients by the consensus panelists. Issues to be addressed were: indications, pain management and anesthesia, timing of application, technique of application, after-intervention care, skin grafting after enzymatic debridement, blood loss, training strategies and learning curve and areas of future research needs. Sixty-eight (68) consensus statements were provided for the use of enzymatic debridement. The degree of consensus was remarkably high, with a unanimous consensus in 88.2% of statements, and lowest degree of consensus of 70% in only 3 statements. This consensus document may serve as preliminary guideline for the use of enzymatic debridement with user-oriented recommendations until further evidence and systematic guidelines are available.

Our initial learning curve in the enzymatic debridement of severely burned hands-Management and pit falls of initial treatments and our development of a post debridement wound treatment algorithm.

INTRODUCTION: Excisional surgical debridement (SD) is still the gold standard in the treatment of deeply burned hands, though the intricate anatomy is easily damaged. Previous studies demonstrated that enzymatic debridement with the bromelain debriding agent NexoBrid® (EDNX) is more selective and thus can preserve viable tissue with excellent outcome results. So far no method paper has been published presenting different treatment algorithms in this new field. Therefore our aim was to close this gap by presenting our detailed learning curve in EDNX of deeply burned hands. METHODS: We conducted a single-center prospective observational clinical trial treating 20 patients with deeply burned hands with EDNX. Different anaesthetic procedures, debridement and wound treatment algorithms were compared and main pitfalls described. RESULTS: EDNX was efficient in 90% of the treatments though correct wound bed evaluation was challenging and found unusual compared to SD. Post EDNX surprisingly the majority of the burn surface area was found overestimated (18 wounds). Finally we simplified our process and reduced treatment costs by following a modified treatment algorithm and treating under plexus anaesthesia bedside through a single nurse and one burn surgeon solely. Suprathel® could be shown to be an appropriate dressing for wound treatment after EDNX. Complete healing (less 5% rest defect) was achieved at an average of day 28. CONCLUSION: EDNX in deep burned hands is promising regarding handling and duration of the treatment, efficiency and selectivity of debridement, healing potential and early rehabilitation. Following our treatment algorithm EDNX can be performed easily and even without special knowledge in burn wound depth evaluation.

Bromelain-based enzymatic debridement and minimal invasive modality (mim) care of deeply burned hands.

The objective was to critically review the data and assess the implications of NexoBrid [NexoBrid-NXB formerly Debrase Gel Dressing-DGD]a in the special field of deep hand burns. Detailed analysis of endpoints in the treatment of hand burn patients was conducted as part of a multi-center, open label, randomized, controlled two-arm study to evaluate the safety and efficacy of NXB enzymatic debridement, comparing it to the current standard of care (SOC). These results were compared to a large cohort of patients treated with NXB in a previous, single arm study. Thirty-one burned hands were treated with NXB and 41 hand burns were in the SOC group. In the NXB group, 4 out of 31 hand burns (12.9%) required some excisional debridement compared to 29 out of the 41 (70.7%) in the SOC group (p<0.0001). Mean percentage of burn wound area excised in the NXB group was 4.4 ± 13.1% compared to 52.0 ± 41.4% in the SOC group (p<0.0001). None of the NXB-treated hands required escharotomy compared to 4 out of the 41 (9.7%) in the SOC group. NXB enzymatic debridement demonstrated a statistically significant reduction in burn wound excision and auto-grafting compared to SOC, and seems to prevent the need for emergency escharotomy. a DGD is produced by MediWound and distributed under the name NexoBrid®.

Le but était de réaliser une révision attentive des données et d'évaluer la place de Nexobrid (Nexobrid-NXB, précédemment Debrase Gel Dressing-DGD) dans l'indication particulière des brûlures profondes de la main. Une analyse détaillée des objectifs dans le traitement des brûlures de la main a été conduite en partie par une étude multicentrique, ouverte, randomisée, contrôlée avec 2 groupes pour évaluer la sécurité et l'efficacité de ce débridement enzymatique par rapport aux soins habituels (Standard of Care ou SOC). Ces résultats ont été comparés à une vaste cohorte de patients traités par NXB dans une étude précédente sur un seul groupe. 31 mains brûlées furent traitées par NXB et 41 dans le groupe SOC. Dans le groupe NXB, 4 sur 31 mains brûlées soit 12,9 % nécessitèrent une excision partielle, alors que 29 sur 41 dans le groupe SOC (70,7 %) (p < 0,0001). La moyenne des zones brûlées excisées dans le groupe NXB était de 4,4 (+ ou - 13,1 %) comparée aux 52,0 (+ ou - 41,4 % du groupe SOC) (p <0,0001). Aucune des mains traitées par NXB ont nécessité une excision totale, comparée à 4 sur 41 du groupe SOC (9,7 % du groupe). Le débridement enzymatique NXB montre une réduction statistiquement significative de l'indication d'excision avec autogreffe par rapport au groupe traité classiquement et semble prévenir la nécessité d'une escarrotomie en urgence.

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.