Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Total Length of Stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ischial and sacral wounds at stage 3 and
- •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.
Arms & Interventions
Control (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.
Intervention: Standard of Care (Wet-to-dry dressings) (Other)
Treatment (NPWT with Instillation)
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.
Intervention: V.A.C.Ulta™ Negative Pressure Wound Therapy System (Device)
Outcomes
Primary Outcomes
Total Length of Stay
Time Frame: 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 Outcomes
- Cost Analysis(Through study completion, approximately 5 months)
- Number of debridements(Through study completion, approximately 5 months)
- Successful closure of pressure sores(2 weeks and 6 weeks post-closure surgery)
Investigators
Robert Galiano
Associate Professor of Surgery
Northwestern University