Phase 2 Trial Results of Complete Debridement With Bromelain-based Enzymatic Debriding Agent

At SAWC Spring 2023, Dr. John C. Lantis II reports the findings from a phase 2 trial that studied complete debridement with a bromelain-based enzymatic debriding agent.

Poster title: Results from a Phase 2 multicenter, randomized, placebo controlled, adaptive design study performed to evaluate safety and efficacy of Bromelain-based enzymatic debridement agent in debridement of Venous Leg Ulcers.

Transcript:

Hello, I'm John Lantis. I'm a vascular surgeon in New York City who's been involved in prospective randomized trials in the wound care field and wound healing and closure for the last 23 years.

The results of the bromelain enzymatic debridement trial are unique in that this is truly a biologic agent being looked at through the FDA process, so therefore going through rigorous control. This is actually a phase 2 trial where the active agent is being looked at versus the placebo gel, which is fundamentally the same gel without the active agent or without the bromelain in it, and then a standard of care arm.

The data here show that the wounds were debrided very, very quickly by the active agent. Interestingly also, a portion of those wounds developed a good granulation bed at the same time. I think one of the things to think of here is a very active, rapidly debriding agent that probably should make the clinician think, okay, what next? I've got the wound debrided, what should I be doing next?

Of note, this trial doesn't answer that. This trial was not designed to answer that. This trial was designed to have a primary endpoint of complete debridement, and in most cases, the wounds were completely debrided within 4 applications of this product.

I think rapid enzymatic debridement is something that the wound care community has been waiting a while to get to, and this trial starts to give us a thought that we're getting closer to having that available to us.