V.A.C. Peel and Place Dressing for Wounds

Recruiting at 3 trial locations

Overseen By Eric Synatschk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Solventum US LLC

Disqualifiers: Pregnancy, Untreated infection, Malignancy, others

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

Compensation: Varies

Number of Visits: 9

Duration: 7 to 14 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on gathering safety and effectiveness data for a new wound dressing, the 3M™ V.A.C.® Peel and Place Dressing, used with 3M's V.A.C.® Therapy, designed to enhance wound healing. It targets individuals with open wounds, such as ulcers or burns, or closed wounds, like surgical incisions, that require additional support to heal. Participants should have wounds suitable for this treatment and be willing to attend all study visits. As an unphased trial, this study provides participants the opportunity to contribute to important research that could improve wound care for many.

Will I have to stop taking my current medications?

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

What prior data suggests that the V.A.C. Peel and Place Dressing is safe for wound treatment?

Research has shown that the 3M™ V.A.C.® Peel and Place Dressing is safe for its intended use. It functions with the V.A.C.® Therapy system to aid wound healing by reducing size and removing fluid. This dressing is already available on the market, and evidence confirms its safety and effectiveness for users.

Following the instructions carefully is important. For example, the dressing should not remain on without active therapy for more than two hours, as this could cause issues. Overall, studies suggest it is well-tolerated when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The 3M™ V.A.C.® Peel and Place Dressing stands out because it combines an innovative dressing with V.A.C.® Therapy, which is a specialized negative pressure wound therapy. Unlike traditional gauze or hydrocolloid dressings, this treatment integrates a peel-and-place application that simplifies the process and maintains consistent pressure on the wound. This method promotes faster healing by efficiently removing exudate and reducing swelling, which is something current options like standard dressings and conventional NPWT systems might not achieve as quickly or effectively. Researchers are excited because this approach could lead to quicker recovery times and improved patient comfort, making wound care more efficient and less burdensome.

What evidence suggests that the V.A.C. Peel and Place Dressing is effective for wound treatment?

Research has shown that the 3M™ V.A.C.® Peel and Place Dressing, when used with V.A.C.® Therapy, helps wounds heal faster. Studies indicate that this treatment not only accelerates healing but also reduces hospital stays, complications, and the need for amputations. The method employs a gentle vacuum effect to enhance wound healing. Patients have reported fewer dressing changes and shorter healing times. These findings suggest that this treatment can make wound care more effective and less painful. ^{5 6 7 8 9}

Who Is on the Research Team?

Sher-ree Beekman

Principal Investigator

Solventum

Are You a Good Fit for This Trial?

This trial is for individuals at least 22 years old with various types of open wounds (like surgical, burns, ulcers) or closed wounds secured by sutures or staples. Participants must be able to attend all study visits and give informed consent themselves or through a legal representative.

Inclusion Criteria

I am 22 years old or older.

I have an open wound, such as a recent surgical wound, burn, or ulcer.

I can give my consent or have someone who can legally do it for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 days

1 visit (in-person)

Treatment

Participants receive the 3M™ V.A.C.® Peel and Place Dressing in conjunction with 3M™ V.A.C.® Therapy

7 to 14 days

Dressing change visits as clinically appropriate, no more than 7 days from dressing application

End-of-Treatment/End-of-Study

Final assessment of wound healing and adverse device effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• 3M™ V.A.C.® Peel and Place Dressing

Trial Overview The study is testing the safety and effectiveness of the V.A.C.® Peel and Place dressing when used with V.A.C.® Therapy on different wound types in a post-market setting.

How Is the Trial Designed?

Group I: 3M™ V.A.C.® Peel and Place Dressing Experimental Treatment 1 Intervention

3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy

Who Is Running the Clinical Trial?

Solventum US LLC

Lead Sponsor

Trials

68

Recruited

10,600+

Bryan Hanson

Solventum US LLC

Chief Executive Officer since 2024

Bachelor's degree in Business Administration from Indiana University

Dr. Ryan Egeland

Solventum US LLC

Chief Medical Officer

MD, trained in Plastic and Reconstructive Surgery

Published Research Related to This Trial

KytoCel, an absorbent wound dressing, was evaluated on 30 community-treated wounds and 10 skin-graft donor sites, showing that 90% of the community wounds either healed or improved, indicating its efficacy in managing wound exudate.

All 10 split-thickness skin graft donor sites healed successfully, and feedback from a focus group of 17 nurses was largely positive, with many noting its availability in local wound care formularies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Product evaluation of an absorbent, antimicrobial, haemostatic dressing. Stephen-Haynes, J., Toner, L., Jeffrey, S.[2019]

Vacuum-assisted closure (V.A.C.® Therapy) was effective in promoting healthy granulation tissue in 52 out of 57 wounds treated, demonstrating its efficacy in managing both clean and infected wounds.

The therapy led to a significant reduction in wound size, with infected wounds decreasing from an average of 55.77 cm² to 48.28 cm², and non-infected wounds from 57.94 cm² to 45.70 cm², although treatment was halted in 5 cases due to poor tissue response related to circulation issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Topical Negative Pressure in the Management of Infected and Non-infected Wounds . Sari, A., Fesli, A., Yener, T., et al.[2015]

V.A.C.® Therapy significantly reduced systemic inflammatory markers, such as peripheral blood monocytes and neutrophils, as well as pro-inflammatory cytokines like IFN-γ and IL-6, indicating a dampening of the inflammatory response during wound healing.

Locally, V.A.C. Therapy also lowered levels of inflammatory substances in wound fluid, including IL-8, TGF-β1, and TNF-α, suggesting it may help manage inflammation and promote healing in full-thickness wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted Closure Therapy Attenuates the Inflammatory Response in a Porcine Acute Wound Healing Model. Norbury, K., Kieswetter, K.[2022]

In a study involving 403 wounds from 206 patients over one year, both the adhesive hydrocellular foam dressing and the self-adherent soft silicone foam dressing showed similar rates of skin stripping, with 5% and 4% respectively, indicating both are safe options.

Despite similar closure rates, the self-adherent soft silicone foam dressing often failed to adhere properly, requiring additional tape for secure application, which discouraged its routine use by nursing staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation study of the properties of two adhesive foam dressings. Viamontes, L., Jones, AM.[2019]

A multicentre clinical trial evaluated the performance of Allevyn hydrocellular dressing for managing exuding wounds, focusing on factors like ease of use, adherence, patient comfort, and safety.

The study found that community nurses found the dressing acceptable and effective, leading to its inclusion in the Drug Tariff for wider availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hydrocellular dressing in the management of exuding wounds in the community. Kurring, PA., Roberts, CD., Quinlan, D.[2019]

In a study of 338 patients using vacuum-assisted closure (V.A.C.) Therapy for surgical and traumatic wounds, 74% achieved their treatment goals within approximately one month, indicating its effectiveness in home care settings.

The success of V.A.C. Therapy was significantly higher for wounds that had been present for a shorter duration, with an 82% success rate for wounds less than 4 weeks old compared to only 33% for those present for over 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using V.A.C. Therapy in home care patients with surgical and traumatic wounds in the Netherlands. Trueman, P., Flack, S., Loonstra, A., et al.[2021]

The study, which analyzed data from multiple wound-care centers in Central Europe, demonstrated that the dressing effectively fought infections in patients with colonized or infected wounds.

In addition to combating infection, the dressing also significantly reduced pain and promoted the healing process for the patients involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experiences of using a silver hydroalginate dressing in Austria, Switzerland and Germany. Kammerlander, G., Afarideh, R., Baumgartner, A., et al.[2016]

The routine use of the dressing in a specialist wound care center effectively eliminated clinical signs of localized infection in most patients.

Patients experienced good healing progression and a noticeable reduction in pain intensity, indicating the dressing's efficacy in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study of the use of a soft silicone silver dressing on a variety of wound types. Meuleneire, F.[2013]

In a study involving 72 patients with Stage II and shallow Stage III pressure ulcers, the transparent absorbent acrylic dressing (TAAD) was found to perform better than the hydrocolloid dressing (HD) in several key areas, including comfort during removal and overall patient satisfaction.

Both dressings showed similar wound healing outcomes, but the TAAD had a longer average wear time of 5.7 days compared to 4.7 days for the HD, indicating it may be more effective for ongoing management of pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, multisite clinical evaluation of a transparent absorbent acrylic dressing and a hydrocolloid dressing in the management of Stage II and shallow Stage III pressure ulcers. Brown-Etris, M., Milne, C., Orsted, H., et al.[2008]

Citations

1. hospitalnews.com hospitalnews.com/solventum-launches-all-in-one-extended-wear-wound-dressing-for-v-a-c-therapy/

The Future of Wound Dressing: V.A.C.® Peel and Place ... New V.A.C.® Peel and Place Dressing Makes Negative Pressure Wound Therapy More Accessible, Less Painful. Solventum today announced the ...

2. solventum.com solventum.com/en-us/home/medical/advanced-wound-care/negative-pressure-wound-therapy/vac-therapy/

3M V.A.C. Therapy Proven results of V.A.C.® Therapy · Fewer hospitalizations · Fewer complications · Fewer amputations · Fewer dressing changes · Faster time to wound healing · Shorter ...

3. liebertpub.com liebertpub.com/doi/10.1089/wound.2023.0096

Preclinical Assessments of a Novel Peel and Place ... RESULTS. Improved wound healing quality with peel and place dressing and NPWT. Wound and periwound visual evaluation. 13-Day Study Group. The full-thickness ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06625385/a-study-evaluating-the-safety-and-efficacy-of-the-3mtm-vac-peel-and-place-dressing

A Study Evaluating the Safety and Efficacy of the 3M™ ... The purpose of this clinical study is to obtain post-market safety and efficacy data when the V.A.C.® Peel and Place dressing is used in ...

5. multimedia.3m.com multimedia.3m.com/mws/media/2234308O/3m-prevena-incision-therapy-clinical-evidence-vascular-surgery.pdf

Clinical Evidence Vascular Surgery For over 25 years, negative pressure vacuum-assisted closure (V.A.C.®) technology has been clinically shown to promote wound healing by reducing.

6. solventum.com solventum.com/en-us/home/f/b5005538007/

3M™ V.A.C.® Peel and Place Dressing Kit Compared to traditional 3M NPWT foam dressings, a V.A.C.® Therapy Unit and a V.A.C® Peel and Place Dressing provides 33%** greater wound volume reduction*. * ...

7. multimedia.3m.com multimedia.3m.com/mws/media/2220711O/3m-v-a-c-system-3m-granufoam-3m-granufoam-silver-3m-v-a-c-whitefoam-dressing.pdf

and - vacⓡ granufoam WARNING: Never leave a V.A.C. Dressing in place without active V.A.C.® Therapy for more than two hours. If therapy is off for more than two hours, remove ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222859.pdf

March 23, 2023 3M Melanie Avila Regulatory Affairs Manager ... evidence that the 3M™ V.A.C. ® Peel and Place Dressing has been found to be safe and effective for the intended users, uses and use environments.

9. multimedia.3m.com multimedia.3m.com/mws/media/2401145O/3m-v-a-c-peel-and-place-dressing-kit-product-guide-en.pdf

3m-v-a-c-peel-and-place-dressing-kit-product-guide- ... Conforms to the wound bed without the need for foam fillers, providing uniform negative pressure delivery and effective fluid removal. 2. Perforated Non- ...