Study Comparing Vacuum-Assisted Negative Pressure Wound Therapy with Standard Wet-to-Dry Dressings for Healing Chronic Pressure Sores

What this Trial Is About

Researchers are evaluating the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy NPWTi in closing chronic pressure sores, compared to the standard wet-to-dry dressings. This post-market, on-label Phase 4 study focuses on patients with stage 3 and 4 ischial and sacral pressure sores that have the potential for a good seal. The goal is to determine if NPWTi can more effectively close these wounds after surgical debridement than traditional care. Participants will be randomly assigned to one of two groups. One group will receive standard care using wet-to-dry dressings, while the other group will be treated with the V.A.C. Ulta Negative Pressure Wound Therapy System with instillation, specifically the V.A.C. VeraFlo Cleanse Choice Dressing System. Treatments will be applied following surgical closure of the pressure sores, with careful monitoring throughout the study. During the study, researchers will track participants for up to 3 months, focusing on the total length of hospital stay as the primary outcome. Secondary outcomes include cost analysis, the number of wound debridements, and successful closure of pressure sores at 2 and 6 weeks after surgery. Participants will undergo regular evaluations to assess wound healing and treatment progress, with safety monitoring continuing throughout the study period.

NPWTi on Closure of Chronic Pressure Sores