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1.
Harefuah ; 163(1): 12-16, 2024 Jan.
Article in Hebrew | MEDLINE | ID: mdl-38297413

ABSTRACT

INTRODUCTION: A war usually requires a new or adjusted set up and needs of all caregivers according to the "new" status. The current war in Israel began on the 7.10.2023. The Israeli Ministries of Defense and Health were in a new status in which they had to complete new requirements according to the use of new weapons, and in numbers and types of injuries that overwhelmed the system from the day the war began. In the past, we published evidence that in times of terror, as in times of war, epidemiology of injuries changes and requires adjustments in human resources, surgical tools and consumables in the Israeli health and defense systems. This article aims to describe the role of specialists in plastic, aesthetic and reconstructive surgery and the first response according to the existing system divided into prevention, preparedness, response and rehabilitation. In the long term rapid response, recruitment of human resources, abilities and flexibility of the system enables overcoming a sudden "new" status as in war, terror and mass casualty events.


Subject(s)
Plastic Surgery Procedures , Surgery, Plastic , Terrorism , Humans , Warfare , Israel/epidemiology
2.
Int Wound J ; 20(10): 4364-4383, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37455553

ABSTRACT

In 2012 the European Medicines Agency approved a pineapple stem-derived Bromelain-based debridement concentrate of proteolytic enzymes (NexoBrid®, MediWound Ltd, Yavne, Israel) for adult deep burns. Over 10 000 patients have been successfully treated with NexoBrid® globally, including in the US. The aim of our study is to perform a systematic review of the current literature on Nexobrid® outcomes. We conducted a literature search in PubMed, Google Scholar, Embase, and other search engines (2013-2023). The online screening process was performed by two independent reviewers with the Covidence tool. The protocol was reported using the Preferred Reporting Items for Systematic Review and Meta-Analyses, and it was registered at the International Prospective Register of Systematic Reviews of the National Institute for Health Research. We identified 103 relevant studies of which 34 were found eligible. The included studies report the positive effects of Nexobrid® on burn debridement, functional and cosmetic outcomes, scarring, and quality of life. Also, they validate the high patient satisfaction thanks to enhanced protocols of analgosedation and/or locoregional anaesthesia during Bromelain-based debridement. Two studies investigate potential risks (coagulopathy, burn wound infection) which concluded there is no strong evidence of these adverse events. NexoBrid® is a safe, selective, non-surgical eschar removal treatment modality. The benefits of Bromelain-based debridement are faster debridement and healing times, reduced operations, length of stay, cases of sepsis, blood transfusions, and prevention of compartment syndrome. Existing evidence suggests that the indications and the role of Bromelain-based debridement are expanding to cover "off-label" cases with significant benefits to the global healthcare economy.


Subject(s)
Bromelains , Burns , Adult , Humans , Bromelains/therapeutic use , Burns/surgery , Debridement/methods , Patient Safety , Quality of Life , Systematic Reviews as Topic
3.
Wound Repair Regen ; 29(6): 899-907, 2021 11.
Article in English | MEDLINE | ID: mdl-34231281

ABSTRACT

Chronic wounds are estimated to affect over 6 million people annually in the United States with an estimated annual cost of $25 billion. Debridement represents a key step in their management and is considered a basic necessity to induce the functional process of tissue repair. However, there is an unmet need for an efficient rapid acting non-surgical debridement agent. Bromelain-based enzymatic debridement has been proven to provide an effective, selective and safe non-surgical debridement in deep burns. EscharEx (MediWound Ltd, Yavne, Israel), is a bromelain-based enzymatic debridement agent currently in development for chronic wounds. The aim of this study was to assess its safety and efficacy in chronic wounds. Seventy-three patients suffering from a lower extremity ulcer of diabetic/venous insufficiency/post-surgical/traumatic aetiology were enrolled in a multicentre, assessor blinded, randomized controlled trial. Patients were randomized to topical treatment by either EscharEx or its gel vehicle for up to 10 daily 4 hour applications, and then continued follow-up for up to 6 months. The EscharEx arm achieved a significantly higher incidence of complete debridement compared to the gel vehicle arm; 55 versus 29% (p = .047), thus meeting the primary endpoint of this study. The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area and wound healing scores during the debridement period. There were no significant differences between the arms in the incidence of complete wound closure (41% in the EsxcharEx arm vs. 53% in the gel vehicle arm) and in the mean time to complete wound closure (70.0 ± 32.8 days in the EsxcharEx arm vs. 65.7 ± 38.4 days in gel vehicle arm). There were no significant safety issues and EscharEx demonstrated a favourable benefit to risk profile.


Subject(s)
Bromelains , Burns , Administration, Topical , Bromelains/therapeutic use , Debridement , Humans , Wound Healing
4.
J Wound Care ; 30(Sup9a): VIi-VIx, 2021 Sep 02.
Article in English | MEDLINE | ID: mdl-34597174

ABSTRACT

AIMS: We describe the development of a novel porcine eschar model and compare the debridement efficacy of various concentrations of a novel bromelain-based enzymatic agent with collagenase. METHODS: Full thickness excisional wounds were created on pigs and injected intradermally with various doses of doxorubicin. Wounds were monitored for a period of 46 days for the development of eschar and wound closure. After determining the optimal concentration and dose of doxorubicin resulting in non-healing eschars, these conditions were used to create additional wounds on another set of animals. The resulting eschars were treated with various concentrations of a novel bromelain-based enzymatic agent (EscharEx-02) or collagenase. The primary endpoint was greater than 95% removal of the central eschar. RESULTS: Consistent eschars composed of two distinct areas (a central area of exudate and slough representing the hard-to-heal wound bed, and a peripheral area of full-thickness mummified necrosis) were seen after injection of doxorubicin (0.5 ml/cm2 of stock solution 0.75mg/ml) at one and six days after wound creation. Complete removal of the central eschar was achieved in all wounds after five and eight treatments with 5% and 2% EscharEx-02 respectively. Complete removal of the central eschar with collagenase was achieved in 0% and 82% of the wounds after 10 and 16 treatments respectively. CONCLUSIONS: We describe a porcine model for creating eschars similar to hard-to-heal wounds in humans. A novel bromelain-based enzymatic debridement agent was more effective than a commercially available collagenase in removing eschars in this wound model.


Subject(s)
Bromelains , Wound Healing , Animals , Bromelains/pharmacology , Exudates and Transudates , Necrosis , Swine
5.
Int Wound J ; 17(5): 1337-1345, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32445271

ABSTRACT

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.


Subject(s)
Bromelains , Burns , Adult , Burns/therapy , Child , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Debridement , Follow-Up Studies , Humans , Randomized Controlled Trials as Topic , Wound Healing
6.
Aesthet Surg J ; 38(5): 557-561, 2018 Apr 06.
Article in English | MEDLINE | ID: mdl-29145580

ABSTRACT

BACKGROUND: Muscle activity contributes to the enhancement of facial aging deformity, blepharospasm, cerebral palsy spasticity, trismus, torticollis, and other conditions. Myotomy of the involved muscles in order to reduce the deformity has variable success rates due to muscle healing and regeneration of activity. OBJECTIVES: The goal of this study was to investigate whether blocking striated muscle activity with Botulinum toxin (BtxA) during the healing time after myotomy alters the healing process and reduces long-term muscle activity. METHODS: Eighteen Sprague Dawley rats where divided into 3 groups: group A (n = 7) underwent myotomy of their Latisimus Dorsi muscle; group B (n = 7) underwent myotomy and injection of BtxA into their severed muscle; group C (n = 4) injection of BtxA only. Muscle strength was tested periodically using a grip test. RESULTS: Starting at week 16 and until the termination of study at week 22, group B (Myotomy + BtxA) showed significant reduction in muscle power compared to the two control groups. CONCLUSIONS: Addition of BtxA injection into a muscle immediately after myotomy may interfere with muscle healing and contribute to a more successful long-term result.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques , Myotomy/methods , Neuromuscular Agents/administration & dosage , Wound Healing/drug effects , Animals , Injections, Intramuscular , Models, Animal , Rats , Rats, Sprague-Dawley , Rejuvenation , Superficial Back Muscles/drug effects , Superficial Back Muscles/innervation , Superficial Back Muscles/surgery , Treatment Outcome
7.
Int Wound J ; 15(5): 769-775, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29696785

ABSTRACT

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.


Subject(s)
Bromelains/therapeutic use , Chronic Disease/therapy , Debridement/methods , Wound Healing/physiology , Wounds and Injuries/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Treatment Outcome , United States , Young Adult
8.
Ophthalmic Plast Reconstr Surg ; 32(6): e131-e132, 2016.
Article in English | MEDLINE | ID: mdl-25233097

ABSTRACT

Invasive sinonasal mucormycosis is a rare fungal infection that usually occurs in immunocompromised or diabetic patients, and it is often fatal. The authors present a case of a woman patient suffering from systemic lupus erythematosus and diabetes mellitus treated with prednisone, presenting with a rapidly progressive rhino-orbital-cerebral mucormycosis. She was successfully treated with combined intravenous antifungal therapy and radical debridement followed by complex defect reconstruction with a free vertical rectus abdominis myocutaneous flap, tissue expander, and ophthalmic prosthesis.


Subject(s)
Eye, Artificial , Facial Dermatoses/surgery , Free Tissue Flaps , Mucormycosis/surgery , Rectus Abdominis/transplantation , Rhytidoplasty/methods , Tissue Expansion/methods , Adult , Facial Dermatoses/diagnosis , Female , Humans , Mucormycosis/diagnosis , Tomography, X-Ray Computed
9.
Aesthet Surg J ; 36(10): NP299-NP304, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27277272

ABSTRACT

BACKGROUND: Defensive medicine (DM) includes medical practices that are aimed at avoiding liability rather than benefitting the patient. DM has not been well characterized among plastic surgeons. OBJECTIVES: The authors examined the extents of intended and unintended DM among members of the Israeli Society of Plastic and Aesthetic Surgery (ISPAS) and identified risk factors for DM. METHODS: A total of 108 ISPAS members were asked to complete a questionnaire that addressed physician attitudes toward DM and intended or unintended DM practices. RESULTS: Seventy-eight surgeons (72.2% response rate) returned the questionnaire, although some questionnaires were returned incomplete. Forty respondents acknowledged practicing DM (ie, DM group), and 33 respondents did not (ie, non-DM group). There were no between-group differences in gender, years of practice, or number of previous litigations. Thirty-one percent of respondents in the DM group indicated that they avoid certain surgical procedures, compared with 6% of respondents in the non-DM group (P = .008). In private practice, 66.2% of respondents stated that they obtain written informed consent twice before surgery, and 100% request preoperative blood-coagulation testing. In contrast, 40% and 74% of respondents in public practice, respectively, acknowledged these behaviors (for consent, P = .027; for testing, P = .0059). Sixty-three percent of respondents prescribe antibiotics for more than 24 hours postoperatively, and this practice was slightly more common in the DM group (34 prescribe antibiotics vs 21 in the non-DM group; P = .079). CONCLUSIONS: DM is highly integrated into the daily medical practices of plastic surgeons in Israel.


Subject(s)
Attitude of Health Personnel , Cosmetic Techniques/trends , Defensive Medicine/trends , Health Knowledge, Attitudes, Practice , Plastic Surgery Procedures/trends , Practice Patterns, Physicians'/trends , Surgeons/psychology , Surgeons/trends , Anti-Bacterial Agents/administration & dosage , Blood Coagulation Tests/trends , Female , Humans , Informed Consent , Israel , Male , Prospective Studies , Surveys and Questionnaires
10.
Harefuah ; 155(5): 281-5, 323, 322, 2016 May.
Article in Hebrew | MEDLINE | ID: mdl-27526555

ABSTRACT

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.


Subject(s)
Bromelains/administration & dosage , Burns/therapy , Debridement/methods , Wound Healing/drug effects , Burns/diagnosis , Burns/physiopathology , Clinical Trials as Topic , Dermatologic Agents/administration & dosage , Drug Discovery , Female , Humans , Israel , Male , Outcome and Process Assessment, Health Care , Trauma Severity Indices
11.
Aesthetic Plast Surg ; 39(4): 640-3, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25990219

ABSTRACT

Breast reconstruction has become standard of care for female patients with breast cancer. The transverse rectus abdominis musculo-cutaneous flap (TRAMf) is the most common method of immediate or delayed autologous breast reconstruction following mastectomy. We share our experience with modified, double back cut of post-mastectomy skin in delayed pedicled TRAMf breast reconstruction, resulting in fish-shaped skin paddle. This sort of back cut is a simple, reliable way to obtain a natural, esthetically pleasant breast mound with inconspicuous hidden scars.


Subject(s)
Mammaplasty/methods , Mastectomy , Myocutaneous Flap , Female , Humans , Time Factors
12.
ScientificWorldJournal ; 2014: 219728, 2014.
Article in English | MEDLINE | ID: mdl-24672301

ABSTRACT

INTRODUCTION: Squamous cell carcinoma is a common tumour of lower lip. Small defects created by surgical resection may be readily reconstructed by linear closure or with local flaps. However, large tumours resection often results with microstomia and oral incompetence, drooling, and speech incomprehension. The goal of this study is to describe our experience with composite free radial forearm-palmaris longus tendon flap for total or near total lower lip reconstruction. PATIENTS AND METHODS: This procedure was used in 5 patients with 80-100% lip defect resulting from Squamous cell carcinoma. Patients' age ranged from 46 to 82 years. They are three male patients and two female. In 3 cases chin skin was reconstructed as well and in one case a 5 cm segment of mandible was reconstructed using radius bone. In one case where palmaris longus was missing hemi-flexor carpi radialis tendon was used instead. All patients tolerated the procedure well. RESULTS: All flaps totally survived. No patient suffered from drooling. All patients regained normal diet and normal speech. Cosmetic result was fair to good in all patients accept one. CONCLUSION: We conclude that tendino-fasciocutaneous radial forearm flap for total lower lip reconstruction is safe. Functional and aesthetic result approaches reconstructive goals.


Subject(s)
Fasciotomy , Forearm/surgery , Lip/surgery , Plastic Surgery Procedures , Surgical Flaps , Tendons/surgery , Aged , Aged, 80 and over , Dermatologic Surgical Procedures , Female , Humans , Male , Middle Aged , Skin
13.
Health Sci Rep ; 7(7): e1829, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39040879

ABSTRACT

Background: Selective bromelain-based enzymatic debridement (BED) has emerged as a valid alternative for the treatment of extensive burns, with Total Body Surface Area (TBSA) > 20%. Autologous skin grafting represents the procedure of choice but the scarcity of donor sites remains the main reconstructive challenge. The modified Meek micro-grafting technique may represent a valid strategy to optimize the final outcome. Methods: A single-cohort retrospective analysis was performed, involving nine burn patients (TBSA > 20%) who underwent both BED and subsequently modified Meek technique. Demographic and clinical data (mechanism of injury, surgical treatment, complications, necessity of re-grafting, further surgery and esthetic outcome) were collected. Results: All patients had large burns of mixed and deep dermal thickness (first, second, and third degree). All burns were enzymatically debrided postadmission and covered by the modified Meek technique. Local infection due to poor general conditions was the main complication for all patients. All but two patients survived. The selectiveness of the enzymatic debridement and dermal preservation seemed to improve the quality of scars resulting from micro-grafting. Evaluations performed at 12 ± 2 months postburn showed superior scar quality compared to areas treated with traditional (sheet/mesh) grafts. Conclusion: Combined BED and Meek techniques may provide an effective synergic combination for the treatment of extensive burns.

14.
Burns ; 50(5): 1138-1144, 2024 06.
Article in English | MEDLINE | ID: mdl-38448317

ABSTRACT

Burns are serious injuries associated with significant morbidity and mortality. In Israel, burn patients are often transferred between facilities. However, unstructured and non-standardized transfer processes can compromise the quality of patient care and outcomes. In this retrospective study, we assessed the impact of implementing a transfer form for burn management, comparing two populations: those transferred before and after the transfer form implementation. This study included 47 adult patients; 21 were transferred before and 26 after implementing the transfer form. We observed a statistically significant improvement in reporting rates of crucial information obtained by Emergency Room clinicians and inpatient management indicators. Introducing a standardized transfer form for burn patients resulted in improved communication and enhanced primary management, transfer processes, and emergency room preparation. The burns transfer form facilitated accurate and comprehensive information exchange between clinicians, potentially improving patient outcomes. These findings highlight the importance of structured transfer processes in burn patient care and emphasize the benefits of implementing a transfer form to streamline communication and optimize burn management during transfers to specialized burn centers.


Subject(s)
Burn Units , Burns , Patient Transfer , Humans , Burns/therapy , Israel , Patient Transfer/organization & administration , Burn Units/organization & administration , Adult , Retrospective Studies , Male , Female , Middle Aged , Emergency Service, Hospital/organization & administration , Aged , Young Adult , Communication
15.
Article in English | MEDLINE | ID: mdl-39338086

ABSTRACT

This study investigates the long-term efficacy of carpal tunnel release surgery (CTR) on patient outcomes. We aimed to assess symptom severity, functional limitations, and quality of life in a large cohort (n = 186) at least five years post-surgery via a retrospective cross-sectional design that evaluated participants using the validated Boston Carpal Tunnel Questionnaire (BCTQ) over a phone interview. The BCTQ measures symptom severity, functional limitations, and quality of life specific to carpal tunnel syndrome. Seventy-three percent (73.1%) of patients reported complete resolution of symptoms and functional limitations (BCTQ = 1) with an average follow-up of 11 years. No statistically significant decline in BCTQ scores was observed over time. Univariate analysis revealed a significant association between poorer outcomes and older age at surgery and current unemployment. Carpal tunnel release surgery demonstrates long-term effectiveness in relieving symptoms and improving function in most patients. These findings contribute to the understanding of CTR's impact on patient well-being beyond short-term outcomes.


Subject(s)
Carpal Tunnel Syndrome , Quality of Life , Humans , Carpal Tunnel Syndrome/surgery , Middle Aged , Male , Female , Retrospective Studies , Aged , Cross-Sectional Studies , Adult , Surveys and Questionnaires , Treatment Outcome
16.
J Burn Care Res ; 45(2): 297-307, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-37715999

ABSTRACT

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.


Subject(s)
Burns , Wound Healing , Adult , Humans , Burns/surgery , Burns/complications , Cicatrix/etiology , Debridement/methods
17.
Expert Opin Biol Ther ; 23(12): 1185-1191, 2023.
Article in English | MEDLINE | ID: mdl-37833828

ABSTRACT

INTRODUCTION: Accurate burn depth assessment and early excision of burn eschar with maximal dermal preservation are key concepts in the optimal care of burn injury. Although excision with knife has long since been standard of care, a newer technique for wound bed preparation utilizing a bromelain-based enzyme has gained popularity worldwide and may offer several advantages. AREAS COVERED: Here we report the pharmacologic properties, evidence for clinical efficacy, safety, and tolerability of anacaulase-bcdb for the treatment of deep partial thickness and full thickness burns. EXPERT OPINION: Anacaulase-bcdb is a safe, non-surgical, selective eschar removal agent. It offers advantages over surgical excision of burn with knife and fulfills two unmet needs: burn depth assessment and dermal preservation during excision. Evidence supports a faster time to complete eschar removal; reduced number of operations; reduction in the amount of autografting, length of stay, and blood loss; prevention of burn induced compartment syndrome; and improved cosmetic outcome.


Subject(s)
Burns , Wound Healing , Humans , Debridement/methods , Burns/surgery , Treatment Outcome , Skin Transplantation/methods
18.
Life (Basel) ; 13(2)2023 Feb 10.
Article in English | MEDLINE | ID: mdl-36836845

ABSTRACT

Since its approval in Europe a decade ago, NexoBrid® enzymatic debridement of deep thermal burns has been gaining acceptance as standard practice around the world. The purpose of this study is to report the first experience with NexoBrid® in the Russian Federation. During 2019-2020, we conducted a post-registration clinical study assessing the safety and treatment results of NexoBrid® enzymatic debridement. The study involved 15 adult patients suffering from deep thermal burns over an area ≤15% of their total body surface area. Patients were treated with NexoBrid® within 3 days of injury, followed by spontaneous or surgical wound closure. Complete eschar removal was achieved in twelve patients, 80% eschar removal in two patients, and 70% in one patient. Complete spontaneous epithelialization of wounds was achieved in 12 patients (80%) within 18 ± 1.9 days after the start of treatment. We did not witness pathological scarring during follow-up, and there were no significant safety issues throughout the study. Early use of NexoBrid® resulted in rapid, effective, and safe eschar removal with good results and sufficient preservation of viable dermis to allow for spontaneous healing in 80% of patients. These results demonstrate the ability to minimize surgical intervention and hopefully lead to better long-term scarring results.

19.
J Burn Care Res ; 44(2): 408-413, 2023 03 02.
Article in English | MEDLINE | ID: mdl-35764058

ABSTRACT

Surgical excision and grafting of deep partial-thickness (DPT) and full-thickness (FT) burns is a cornerstone of wound care. The use of commercially available topical enzymatic agents has been limited due to slower and less complete eschar removal than surgical excision. Using a porcine model of DPT and FT burns, we compared the eschar removal efficacy of a bromelain-enriched enzymatic agent derived from the stems of pineapple plants and a commercially available collagenase. We created 40 DPT and 40 FT burns on four anesthetized Yorkshire pigs. Eschar removal was initiated 24 hours later. Two pigs each were randomly assigned to collagenase or the bromelain-enriched agent. The bromelain-enriched agent was applied topically once for 4 hours followed by a 2-hour soaking. The collagenase was applied topically daily until complete removal of eschar or for up to 14 days. All bromelain-enriched treated FT burns underwent complete removal of the eschar after a single application while none of the collagenase-treated FT burns underwent complete removal of the eschar even after 14 days of treatment. All bromelain-enriched treated DPT burns had complete eschar removal after the single application. None of the collagenase-treated DPT burns experienced complete removal of eschar after 10 days; by day 14, 35% had complete eschar removal, 30% had >50% eschar removed, and 35% had <50% eschar removed. We conclude that eschar removal is quicker and more complete with the bromelain-enriched compared with collagenase debriding agent.


Subject(s)
Burns , Wound Healing , Animals , Bromelains/pharmacology , Bromelains/therapeutic use , Burns/drug therapy , Burns/surgery , Collagenases/pharmacology , Debridement , Swine
20.
Burns ; 49(1): 80-90, 2023 02.
Article in English | MEDLINE | ID: mdl-35177282

ABSTRACT

INTRODUCTION: In recent years, it has become clear that the burn eschar in deep burns can be selectively removed using the enzymatically debriding agent NexoBrid® (EDNX). In deep partial-thickness burns, such selective debridement preserves all non-injured dermis, which is sometimes sufficient for spontaneous re-epithelization. Nevertheless, it can be extremely challenging to determine exactly what and when to operate after an EDNX procedure. In this manuscript, we sought to investigate the clinical aspect of the enzymatically debrided wound bed of laser Doppler imaging (LDI)-confirmed deep dermal and full-thickness burns after NexoBrid® application. This to evaluate the residual wound healing capacity and implement specific indications for surgical therapy after enzymatic debridement. MATERIAL AND METHODS: Mainly LDI-blue areas, determined between 48 h and 5d after burn and afterwards treated with EDNX were selected. Six practical and three expert EDNX users evaluated the high-quality digital images of the wound beds immediately post NexoBrid® removal and after a 2 h wet-to-dry (WTD) dressing period. RESULTS: One hundred and two mainly LDI-blue areas in 32 patients were analyzed. Regarding the early decision-making, there were no significant differences in the wound bed evaluations, wound healing assessment and treatment decision of all 9 EDNX users post EDNX removal versus post WTD. Moreover, there was a good to excellent consensus between the practical and expert EDNX users in the individual wound bed evaluations. Even in the evaluation of a newly developed wound bed color code, with 7 different colors/patterns to choose from, the consensus was 80%. There was also an 84% consensus on the decision whether or not to operate. All mainly LDI-blue areas with incomplete enzymatic debridement, determined during clinical investigation by expert EDNX users, required surgery. Additionally, the expert investigators demonstrated that the following wound bed characteristics were independent predictors of the need for surgical treatment: visible fat lobules (p = 0.028), translucent fat lobules (p < 0.001), dermal step-off in the wound bed (p < 0.001), visible blood vessels (p < 0.001) and coagulated blood vessels (p = 0.023). Also, higher color code ranges on our own developed wound bed classification were significantly related to a surgical intervention (p = 0.006). When including the LDI flux values, the perfusion units were significantly different (p < 0.001) between the exclusively LDI-blue areas treated conservatively (mean 145.7) and the areas ultimately treated with autografts (mean 119.5). CONCLUSION: To the best of our knowledge, this study is the first to address the clinical wound bed evaluation of LDI-confirmed deep burns after NexoBrid® application. Based on our results, it is recommended to evaluate the wound bed twice: immediately after removing NexoBrid® to assess the viability of the wound bed and after the WTD period to reach a more complete decision. During these evaluations, wound bed characteristics such as incomplete debridement, visible and/or translucent fat lobules, visible and/or coagulated blood vessels and a dermal step-off in the wound bed combined with a higher range (4-5) in the newly developed wound bed color code should lead to an early and reliable decision for skin grafting. For burn centers using LDI, mean flux values below 119.5PU - in addition to the above-mentioned wound bed evaluation - are a clear indicator for surgical therapy.


Subject(s)
Bromelains , Burns , Humans , Debridement/methods , Bromelains/therapeutic use , Burns/surgery , Burns/drug therapy , Wound Healing , Skin
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