Bromelain-based enzymatic debridement agent rapidly treats venous leg ulcer wounds

Key takeaways:

• Complete debridement was achieved by 63% of patients treated with EscharEx vs. 30.2% and 13.3% of comparison groups.
• The average time to complete debridement was 9 days.

A new bromelain-based enzymatic debridement product was effective at rapidly debriding venous leg ulcer wounds without pain, according to this study.

“Venous leg ulcers represent about 10% to 15% of all wounds,” John C. Lantis, MD, site-chief of surgery at Mount Sinai West Hospital and principal investigator of the study, told Healio. “In this study we were able to adequately debride the venous leg ulcers while also improving the granulation bed.”

Current methods of debridement, which include enzymatic and autolytic agents, are currently slow, according to the study. However, in this study, a debridement agent called EscharEx (MediWound Ltd.) was quickly efficacious.

EscharEx, also known as EX-02 formulation, is a bromelain-based enzymatic debridement agent that is currently being developed for the treatment of chronic wounds. In this study, Lantis and colleagues evaluated the efficacy of the formulation in debriding venous leg ulcers compared with placebo and a nonsurgical standard of care.

A total of 119 patients with venous leg ulcers were randomly assigned to receive EscharEx (n = 46), placebo (n = 43) or standard of care (n = 30) topically every day up until reaching complete debridement or up to eight treatments within 2 weeks. Follow-up occurred in the 14 weeks following treatment. The placebo was the gel vehicle of the active agent.

Results showed that 63% (n = 29) of patients treated with EscharEx achieved complete debridement vs. 30.2% (n = 13) of patients in the placebo group and 13.3% (n = 4) of patients in the nonsurgical standard of care group (P = .004 and P < .001, respectively).

Patients treated with EscharEx quickly achieved complete debridement at an average of 9 days (95% CI, 5-15) vs. the nonsurgical standard of care and placebo groups averages of 59 days (95% CI, 30-85; P = .016) and 63 days (95% CI, 21-93; P = .004), respectively.

A total of 65 patients reported adverse events, including 52.2%, 62.8% and 46.7% of the EscharEx, placebo and nonsurgical standard of care groups, respectively. No deaths were reported.

“The only product in the market at the moment is a product that is much slower for debridement,” Lantis said. “It is used widely because there is no danger profile to it, but I think clinicians would like to have a product that is more efficacious and faster.”

Like slower products on the market, this product had a safe profile despite the notoriety surrounding bromelain.

“There has been this generalized notion that bromelain is painful and anything more effective is painful,” Lantis told Healio. “But the data show that there was no increase in pain and no increase in complications.”

According to Lantis, this study did not show a significant change in closure rates among the therapies, but they have plans to pursue this endpoint actively in their next study.

For more information:

John C. Lantis, MD, can be reached at john.lantis@mountsinai.org.