Disruptive Therapy for Burn Care
NexoBrid, a concentrate of proteolytic enzymes enriched in bromelain, is an easy to use, topically-applied product that removes eschar in four hours and does not harm the surrounding healthy tissues. Eschar removal is a critical first step in the treatment of severe burns. Under existing standard of care, burn eschar may be removed either by surgical approach, primarily surgical excision, which is traumatic and may result in loss of blood and viable tissue or by non-surgical approach, employing certain existing topical agents that have been found to be minimally effective or that take a significantly longer period of time to work.
NexoBrid’s rapid and selective debridement alleviates the known risks associated with eschar, such as infection, eventual sepsis, wound deterioration and consequential scarringand it allows physicians to reach an informed decision on further treatment at an earlier stage by direct visual assessment of the actual burn depth.
Furthermore, NexoBrid minimizes the burden associated with invasive surgical procedures, reduces the need for skin grafting and sacrifice of healthy tissue from donor sites on a patient’s body and generally results in a more favorable overall long-term patient outcome.
Severe burns require specialized care in hospitals or burn centers. Approximately 100,000 patients with severe burns are hospitalized every year in the United States and Europe. The severe burn patients are predominantly treated by specialists in approximately 250 burn centers in Europe and the United States, as well as at burn units of large hospitals.
NexoBrid was classified by BARDA as medical countermeasure for thermal and chemical burns address the public health preparedness gap especially for escher removal needs of a large number of patients in the event of burn mass casualty incident.
How to Use
NexoBrid removes the eschar and does not harm surrounding viable tissue, in the majority of cases, after only a single 4-hour topical application at the patients’ bedside. This early, non-surgical, successful eschar removal, allows the physician to diagnose the burn depth simply by direct visual assessment of the debrided clean wound bed and reach an informed decision on further treatment.
Furthermore, NexoBrid effective eschar removal significantly reduces the extent of surgery required, without sacrificing the surrounding healthy tissues. The application is easy-to use and can be applied by a physician or a nurse.
NexoBrid’s effective and selective activity is mediated by the proteolytic activity of the enzymes, which leads to degradation of denatured collagen.
NexoBrid has been investigated in hundreds of patients across 22 countries and four continents in nine completed Phase 2 and Phase 3 and post-marketing clinical studies.
Our U.S. Phase 3 study (DETECT) evaluated the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to SOC in 175 hospitalized patients with severe burns with twelve month and twenty four month safety follow-ups. The study met its primary endpoint with statistical significance. Patients treated with NexoBrid demonstrated a significantly higher incidence of complete eschar removal compared with patients treated with the Gel Vehicle. The study included secondary endpoints that were all met with statistical significance and provided further insight on several efficacy parameters:
(i) Patients treated with NexoBrid demonstrated shorter time to achieve complete eschar removal compared with patients treated with Standard of Care (SOC); (ii) Patients treated with NexoBrid demonstrated a significantly lower incidence of surgical eschar removal compared with patients treated with SOC; (iii) and Patients treated with NexoBrid incurred significantly lower blood loss during the eschar removal procedure compared with patients treated with SOC. In addition, Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC. The overall safety profile of NexoBrid in the study is consistent with the safety data known from previous studies. The twelve- and twenty four-month patients’ follow-up safety data of cosmesis, function and quality of life were found to be comparable across all study arms, and no safety signals were observed.
Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, nonsurgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid would reduce need for surgery while achieving similar esthetic and unctional outcomes as SOC.
Conclusions: Enzymatic debridement with NexoBrid resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns.
Bromelain-based Enzymatic Debridement (ED) 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.
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.