RecruitingPhase 4

NPWTi on Closure of Chronic Pressure Sores

United States62 participantsStarted 2022-09-26

Plain-language summary

The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ischial and sacral wounds at stage 3 and 4.
✓. Any pressure sore that has the potential for a good seal.

Exclusion criteria

✕. Any pressure sore that does not have potential for a good seal.
✕. Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
✕. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
✕. Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.

What they're measuring

Total Length of Stay

Timeframe: up to 3 months

Trial details

NCT IDNCT05598398

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Robert Galiano, MD

3129267037 robert.galiano@nm.org

View on ClinicalTrials.gov More Pressure Sore trials