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NPWTi on Closure of Chronic Pressure Sores

Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• V.A.C.Ulta™ Negative Pressure Wound Therapy System (device)
• Standard of Care (Wet-to-dry dressings) (other)

Sponsor: Northwestern University · Participants: 62 · Started: Sep 26, 2022

Contact the study team

• Robert Galiano, MD · Phone: 3129267037
• Kristin Huffman, B.S. · Phone: 3129267037

Official record on ClinicalTrials.gov — NCT05598398

Locations in the U.S.

Conditions

• Pressure Sores

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.