NPWTi for Pressure Sores

Overseen By Robert Galiano, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Disqualifiers: Fecal incontinence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5 months

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert Galiano, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for individuals with stage 3 or 4 pressure sores located on the ischial or sacral areas, which can be sealed effectively. It's not suitable for those without a good seal potential, pregnant women, patients with fecal incontinence, or anyone deemed unfit for surgery due to age, BMI, or other health issues.

Inclusion Criteria

I have deep wounds on my lower back or buttocks.

I have a pressure sore that can heal well.

Exclusion Criteria

You have a pressure sore that cannot be properly covered or sealed.

My doctor thinks surgery isn't safe for me due to my age, weight, or other health issues.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NPWTi or wet-to-dry dressings for treatment of pressure sores

5 months

Regular visits for dressing changes and assessments

Follow-up

Participants are monitored for wound closure and other outcomes post-treatment

1 year

Assessments at 2 weeks, 6 weeks, and 1 year post-closure surgery

Treatment Details

Interventions

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

Trial Overview The study tests if the V.A.C.Ulta™ Negative Pressure Wound Therapy System (NPWTi) is more effective at closing chronic pressure sores than standard wet-to-dry dressings after debridement (removal of damaged tissue).

Participant Groups

Group I: Treatment (NPWT with Instillation) Experimental Treatment 1 Intervention

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.

Group II: Control (Wet-to-dry dressings) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania