NPWTi on Closure of Chronic Pressure Sores

Phase 4

Recruiting

• Conditions: Pressure Sore
• Interventions: Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System; Other: Standard of Care (Wet-to-dry dressings)

• Registration Number: NCT05598398
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

Exclusion Criteria

1. Any pressure sore that does not have potential for a good seal.
2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment (NPWT with Instillation)	V.A.C.Ulta™ Negative Pressure Wound Therapy System	Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.
Control (Wet-to-dry dressings)	Standard of Care (Wet-to-dry dressings)	Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.

Primary Outcome Measures

Name	Time	Method
Total Length of Stay	up to 3 months	Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery

Secondary Outcome Measures

Name	Time	Method
Cost Analysis	Through study completion, approximately 5 months	Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.
Number of debridements	Through study completion, approximately 5 months	Record the total number of debridements performed at the wound site throughout the duration of the study
Successful closure of pressure sores	2 weeks and 6 weeks post-closure surgery	Patients will be assessed for proper closure of the wound

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States