NexoBrid® Clinical Study Design
The safety and efficacy of NexoBrid were evaluated in two clinical studies.1
Study 1 (Detect; NCT02148705)1
Three-arm Study with 3:3:1 Ratio
NexoBrid (n=75) vs SOC (n=75) vs Gel Vehicle (n=25)
- Randomized, controlled, assessor-blinded, three-arm study
- To evaluate the safety and efficacy of NexoBrid in comparison to standard of care (SOC) treatment and gel vehicle (placebo)
- SOC included both surgical and non-surgical eschar removal methods per the investigators’ discretion
- 175 randomized subjects with deep partial thickness (DPT) and/or full thickness (FT) thermal burns with ≤30% body surface area (BSA)
- Subjects had one or more target wounds (TWs) to be treated for eschar removal. The mean percentage BSA of all TWs per subject was 6.1%. 82% of subjects had one to two TWs
Limitations:
Not studied in burns >30% TBSA, children, pregnant or nursing women, patients with cardiopulmonary disease, or patients with poorly controlled diabetes.2
Primary Endpoint (1°): NexoBrid vs Gel Vehicle1
Incidence of ≥95% eschar removal at the end of the topical treatment period
Secondary Endpoints (2°): NexoBrid vs SOC1
- Median time to ≥95% eschar removal
- Incidence of excision for eschar removal*
Safety Endpoint: NexoBrid vs SOC1,2
- Estimated median time to ≥95% wound closure
Study 2 (NCT00324311)1
Two-arm study with 1:1 Ratio
NexoBrid (n=75) vs SOC (n=81)
- Multicenter, open-label, randomized, two-arm study
- To evaluate the safety and efficacy of NexoBrid in comparison to SOC treatment
- SOC included both surgical and non-surgical eschar removal methods per the investigators’ discretion
- 156 randomized subjects with DPT and/or FT thermal burns with ≤30% BSA
Limitations:
Not studied in burns >30% TBSA, patients with full or partial thickness facial burns, perineal and/or genital burns, pregnant women or nursing mothers, poorly controlled diabetes, and patients with cardiopulmonary disease.2
Primary Endpoints (1°): NexoBrid vs SOC1
Incidence of excision for eschar removal of DPT wounds (per wound)*
Percent treated DPT wound autografted (per wound)
Secondary Endpoints (2°): NexoBrid vs SOC1
- Incidence of excision for eschar removal of DPT wounds (per subject)†
- Estimated median time to ≥95% wound closure (per subject)
*Measured the incidence of excision for eschar removal following treatment with NexoBrid vs standard of care (SOC), which included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.
†Assessment per subject was an exploratory analysis.
