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
Solventum US LLC
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.
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…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject is at least 22 years old at the time of consent. 2. Subject or legally authorized representative (LAR) is able to provide informed consent. 3. Subject has a wound deemed appropriate for treatment with a V.A.C.® Peel and Place dressing (used in conjunction with 3M™ V.A.C.® Therapy), according to the instructions for use for the dressing, including the following wound types: * an open wound: traumatic wound, dehisced surgical wound within 30 days of surgery, burn, venous ulcer, diabetic ulcer, or pressure ulcer Note: Prior to initial placement, the wound may b…
Interventions
- Device3M™ 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
Locations (3)
- IU Health Methodist HospitalIndianapolis, Indiana
- Washington University - Barnes Jewish HospitalSt Louis, Missouri
- St. Luke's University HospitalBethlehem, Pennsylvania