Bromelain‐based enzymatic debridement of chronic wounds: Results of a multicentre randomized controlled trial

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

Bromelain‐based enzymatic burn debridement: A systematic review of clinical studies on patient safety, efficacy and long‐term outcomes

“…They found faster healing with ESX (55.1% vs. 29.2% gel group) and complete debridement with 10 daily treatments (7.6 ± 4.1 ESX vs. 8.4 ± 4.1 days gel group). There were no significant safety issues and ESX demonstrated a favourable benefit to risk profile in 6 months follow‐up 49 …”

“…There were no significant safety issues and ESX demonstrated a favourable benefit to risk profile in 6 months follow-up. 49 Schulz et al performed a clinical trial including 26 patients with deep facial burns, where they found significantly superior functional and cosmetic outcomes from NXB compared to surgical debridement (SD) based on a series of objective readings, e.g., exameter ® MX 180 that measures scar erythema and melanin, and Patient and Observer Scar Assessment Scale (POSAS). 50 Rosenberg et al (2014) reported promising results from BBD in a multicenter RCT (NCT #: NCT00324311) with 182 patients.…”

Uma revisão abrangente de abordagens cirúrgicas e não cirúrgicas para tratamento de feridas crônicas: estratégias atuais e inovações emergentes

“…Os componentes naturais desses tratamentos não cirúrgicos são adequados para a cicatrização de feridas [6]. De fato, um estudo de controle randomizado demonstrou que o mel pode ser usado como um agente de desbridamento não cirúrgico para feridas crônicas [7].…”

Positionspapier der Initiative Chronische Wunde (ICW) e. V. zur Nomenklatur des Débridements chronischer Wunden

“…Wörtlich wird als Proteolyse der Abbau von Eiweiß bezeichnet. Für die Wundbehandlung werden beispielsweise Produkte mit Bromelain, Kollagenase oder Streptokinase und Streptodornase genutzt [ 22 , 26 ]. Auch das proteolytische Débridement ist eher schmerzlos, einfach und sicher durchzuführen.…”