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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Negative Pressure Wound Therapy with instillation (NPWTi) to determine if it heals chronic pressure sores more effectively than the usual wet-to-dry dressings. Pressure sores, or bedsores, are painful skin wounds that occur when someone remains in one position for too long. The trial compares the new NPWTi system, specifically the V.A.C.Ulta™ Negative Pressure Wound Therapy System, to traditional dressings to identify which method closes these sores more effectively. Individuals with stage 3 or 4 ischial or sacral pressure sores that can be well-sealed might be suitable candidates for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for the V.A.C.Ulta™ Negative Pressure Wound Therapy System?

Research has shown that the V.A.C.Ulta™ Negative Pressure Wound Therapy System (NPWTi) is safe for use. The FDA has approved this system for treating various wounds, including chronic and injury-related ones. It is designed to clean and heal wounds more effectively. In past studies, patients using this therapy experienced positive results and tolerated the treatment well. No major reports of serious side effects or problems have emerged. This suggests that the treatment is generally safe and could be a good option for those dealing with chronic pressure sores. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the V.A.C.Ulta™ Negative Pressure Wound Therapy System because it offers a unique approach compared to the standard wet-to-dry dressings typically used for pressure sores. Unlike traditional methods that rely on passive absorption, this system uses Negative Pressure Wound Therapy with Instillation (NPWTi), which actively cleanses the wound by delivering a cleansing solution and then applying negative pressure to remove infectious materials. This innovative method has the potential to enhance healing by maintaining a clean wound environment, reducing the risk of infection, and promoting faster tissue regeneration.

What evidence suggests that the NPWTi system is effective for closing pressure sores?

Research has shown that the V.A.C.Ulta™ Negative Pressure Wound Therapy System, which participants in this trial may receive, effectively aids in healing pressure sores when combined with a special liquid. Studies have found that this treatment can lead to faster healing and fewer surgeries compared to standard methods. Specifically, patients using this system experienced quicker recovery times for their wounds. The system works by gently applying suction and liquid to clean and promote healing in wounds. This approach has shown great promise in treating both long-lasting and new wounds, making it a strong option for those with pressure sores. Meanwhile, the control group in this trial will receive standard care with wet-to-dry dressings. ^{1 6 7 8 9}

Who Is on the Research Team?

Robert Galiano, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12207569/

Effectiveness of Negative Pressure Wound Therapy With ... This systematic review provides real‐world evidence demonstrating the effectiveness of NPWTi‐d with ROCF‐CC in the hydromechanical removal of infectious ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10088847/

Clinical outcomes of negative pressure wound therapy with ... This study aims to compare the efficacy between negative pressure wound therapy with instillation (NPWTi) and standard negative pressure wound therapy for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05598398?term=bed%20sore%20studies&viewType=Table&rank=7

NPWTi on Closure of Chronic Pressure Sores 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1748681524007010

Effectiveness of negative-pressure wound therapy with ... In this study, patients with acute traumatic wounds who received NPWTi-d experienced shorter wound closure time and fewer surgical procedures.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221585.pdf

3M VAC Veraflo Cleanse Choice Dressing Kit, 3M Veraflo ... The V.A.C.ULTA™ Negative Pressure Wound. Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, ...

6. multimedia.3m.com multimedia.3m.com/mws/media/2023861O/negative-pressure-wound-therapy-portfolio.pdf

Negative pressure wound therapy portfolio Veraflo Cleanse Choice™ Dressing, in conjunction with 3M™ Veraflo™ Therapy, can be used to cleanse the wound, promote wound healing and facilitate the removal.

7. solventum.com solventum.com/en-us/home/medical/advanced-wound-care/negative-pressure-wound-therapy/veraflo-therapy/

3M Veraflo Therapy ® Ulta Negative Pressure Wound Therapy System Safety Information and 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing System Application Instructions.

8. multimedia.3m.com multimedia.3m.com/mws/media/2121207O/3m-v-a-c-ulta-4-therapy-system-brochure-singapore.pdf

Four therapies, one 3M™ V.A.C.® Ulta 4 Therapy System A randomized study evaluating the impact of negative pressure wound therapy on post-op high risk patients, compared Prevena Therapy to standard gauze dressings.

9. gdmedical.nl gdmedical.nl/wp-content/uploads/2018/05/350159e_IFU_VeraFlo_Cleanse_-_WEB0.pdf

V.A.C.UltA™ NegAtiVe PressUre WoUNd therAPy system ( ... VeraFlo™ Dressing. This data indicates that V.A.C VeraFlo Cleanse™ Dressing has increased mechanical strength and provides a less robust granulation tissue ...