NCT06625385

A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing

A Post-market, Prospective, Multi-center, Single-arm Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing Used in Conjunction With 3M™ V.A.C.® Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a prospective, post-market, multi-center, single-arm study. A target of 90 enrolled Subjects with 1 enrolled study wound per Subject is planned for this study, including 60 open wounds (10 for each type of open wound) and 30 closed or covered wounds (10 for each type of closed/covered wound). The entire duration of the study is expected to last approximately 2 years. Individual Subject participation is expected to last up to 20 days, including a screening period lasting up to 5 days, the day of initial treatment, dressing change visits as clinically appropriate but no more than 7 days from dressing application, and an end-of-treatment (EOT)/end-of-study (EOS) visit between Day 7 and Day 14 after the initial dressing application.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	3M™ V.A.C.® Peel and Place Dressing	Application of 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2024-10-03
• Last updated: 2026-02-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study