NPWTi on Closure of Chronic Pressure Sores

Northwestern University

Status and phase: Enrolling; Phase 4

Conditions: Pressure Sore

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05598398

STU00216075

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Control (Wet-to-dry dressings)

Active Comparator group

Description:

Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.

Treatment:

Other: Standard of Care (Wet-to-dry dressings)

Treatment (NPWT with Instillation)

Experimental group

Description:

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.

Treatment:

Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System