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

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Solventum US LLC

Disqualifiers: Pregnancy, Untreated infection, Malignancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 conjunction with 3M™ V.A.C.® Therapy.

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 data supports the effectiveness of the V.A.C. Peel and Place Dressing treatment?

Research shows that vacuum-assisted closure (V.A.C.) therapy, similar to the V.A.C. Peel and Place Dressing, is effective in managing various types of wounds, with over 70% of patients achieving their treatment goals. It helps reduce inflammation and promotes healing, making it a promising option for wound care. ^{1 2 3 4 5}

What makes the V.A.C. Peel and Place Dressing treatment unique compared to other wound treatments?

The V.A.C. Peel and Place Dressing is unique because it combines negative pressure wound therapy (a method that uses suction to promote healing) with an easy-to-apply dressing, potentially offering more effective wound healing and convenience compared to traditional dressings that may not adhere well or require additional tape. ^{5 6 7 8 9}

Research Team

Sher-ree Beekman

Principal Investigator

Solventum

Eligibility Criteria

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

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

Trial Timeline

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

Treatment Details

Interventions

• 3M™ V.A.C.® Peel and Place Dressing (Wound 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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical experiences of using a silver hydroalginate dressing in Austria, Switzerland and Germany. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Topical Negative Pressure in the Management of Infected and Non-infected Wounds . [2015]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Evaluation study of the properties of two adhesive foam dressings. [2019]

7. United States 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. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Product evaluation of an absorbent, antimicrobial, haemostatic dressing. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of a hydrocellular dressing in the management of exuding wounds in the community. [2019]