Enzymatic debridement with proteolytic enzymes enriched in bromelain vs surgical debridement for burn wound management: a randomized open-label clinical trial

Abstract

BACKGROUND. Early surgical debridement followed by autografting is currently the gold standard treatment for deep burns. However, tangential debridement is considered to be a complicated technique with several associated morbidities, including blood loss, surgical aggression and poor selectivity in the case of intermediate and extensive burns. Oftentimes the removal of the eschar is associated with a loss of healthy dermal tissue and a decrease in the skin's ability to regenerate, requiring coverage with autografts. The use of a new enzymatic debrider has recently been proposed, a bromelain-enriched proteolytic enzyme concentrate, which appears to exhibit selectivity towards necrotic tissue, completely debriding the eschar and allowing spontaneous re-epithelialization from healthy dermal remnants. This product has proven to be effective and selective, having an impact on reducing the number of surgical interventions to which a large burn patient is exposed, reducing hospitalization time, as well as reducing the rate of escharotomies, improving post-burn cicatrization, and improving the patient's degree of satisfaction. OBJECTIVES. The aim of this study is to evaluate if the use of enzymatic debridement with CPE-B in the treatment of deep thermal burns affecting over 15%TBSA is more effective than the actual SOC, being its action more specific towards the necrotic tissue, achieving a complete debridement of the eschar and so reducing the need for surgical intervention and its associated morbidities. STUDY DESIGN AND POPULATION. A randomized, open-label and controlled clinical trial was designed with 562 patients (TBSA over 15%) admitted in the Vall d'Hebron Burn Unit between March 2021 and September 2023 who will meet inclusion criteria. METHODS. The sample will be randomly assigned to one group of intervention: 271 patients will be included in the control group and will be treated with tangential excision, and 291 will be treated using CPE-B, 20 of them will be used as a pilot test. The main outcome will be total mortality rate. Other covariates will be considered such as: need for surgery and autografting, hospitalization time, escharotomies rate, hypertrophic scarring rate