WoundNCT06625385
A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing
A study testing 3M™ V.A.C.® Peel and Place Dressing in people with Wound, run by Solventum US LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound
- What is being tested?
- 3M™ V.A.C.® Peel and Place Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 22 years old at the time of consent.
- Subject or legally authorized representative (LAR) is able to provide informed consent.
- 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 be debrided, as clinically indicated
- a closed or covered wound secured with sutures or staples: closed surgical incision, skin flap closure, or skin graft (recipient site)
- Subject is willing and able to attend all study visits.
Who cannot join
- Subject is pregnant or lactating prior to application of the initial dressing. *
- Women who have had surgical sterilization by a medically accepted method (ie, tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing.
- Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
- Subject has been diagnosed with a malignancy in the wound.
- Subject has untreated osteomyelitis or untreated cellulitis in the wound.
- Subject has an untreated systemic infection.
Show all 30Show fewer
- Subject has active cellulitis in the peri-wound area.
- Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
- Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures or would compromise assessment of endpoints (wound/peri-wound condition).
- Subject has had radiation directly to the wound area.
- Subject received hyperbaric oxygen therapy within 30 days before the initial application of a V.A.C.® Peel and Place dressing.
- Subject has been diagnosed with a major vascular deficit limiting arterial inflow into the wound region, as determined by the investigator's interpretation of the subject's medical history.
- In the case of a lower extremity wound, the Subject has one of the following:
- an ankle brachial index < 0.8;
- no palpable pulse; or
- no discernable audio Doppler signal.
- Individual wounds are to be excluded from the study if they meet any of the following criteria
- Wound has necrotic tissue and/or eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, the V.A.C.® Peel and Place dressings may be used.
- Wound contains a non-enteric or unexplored fistula(s) in the wound bed.
- Wound has tunneling.
- Wound has undermining that is ≥ 2 cm in any direction from the wound edge.
- Wound site has inadequate hemostasis, as determined by the investigator.
- Wound has exposed vessels, anastomotic sites, organs, or nerves that cannot be protected prior to placement of the V.A.C.® Peel and Place Dressings.
- Wound has a depth greater than 2 cm (for small dressings), 4 cm (for medium dressing size), or 6 cm (for the large dressing size).
- The wound received, within 30 days before initiating V.A.C.® Therapy, treatment with any of the following:
- any previous negative pressure wound therapy device.
- growth factors.
- bioengineered tissue products, eg, skin or dermal substitutes.
- Wound was closed with tissue adhesive.
- Wound has, in the opinion of the Investigator, any characteristic that would make it unsuitable for the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Monica Hosler
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Kaitlyn Depinet, NP
- Recruiting
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Jen McCarthy
Bryan Sato
About this study
Official title: 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
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.
Read the 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
- Being tested
- 3M™ V.A.C.® Peel and Place Dressing
- Keywords
- Open, Closed
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ V.A.C.® Peel and Place DressingDevice
Application of 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy
| Study group | Role | What they receive |
|---|---|---|
| 3M™ V.A.C.® Peel and Place Dressing | Experimental | 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy Receives: Device: 3M™ V.A.C.® Peel and Place Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of (ADEs)
The incidence of adverse device effects (ADEs)
Measured: 14 days
Secondary outcomes (4)
Percentage of closed surgical incisions and skin flaps that remain closed
The percentage of closed surgical incisions and skin flaps that remain closed throughout treatment
Measured: 14 days
Percentage of skin grafts with ≥ 90% graft take
The percentage of skin grafts with ≥ 90% graft take at the end of treatment
Measured: 14 days
Percentage of open wounds with evidence of healing
The percentage of open wounds with evidence of healing, as evidenced by any of the following:
- decrease in total wound area (cm2) from baseline to the end of treatment,
- decrease in total wound volume (cm3) from baseline to the end of treatment,
- decrease in average wound depth from baseline to the end of treatment,
- increase in the percentage of the wound with red color composition (signifying healthy, viable tissue), from baseline to the end of treatment,
- improved score for exudate amount from the first dressing change to the end of treatment
- improved score for peripheral tissue edema from baseline to the end of treatment
- new epithelialization from baseline to the end of treatment, or
- wound is deemed ready for closure (via delayed primary closure, graft, flap or allowed to epithelialize) at any time from baseline to the end of treatment
Measured: 14 days
Overall rate of wound healing for both open wounds and closed/covered wounds
The overall rate of wound healing for both open wounds and closed/covered wounds, as evidenced by the aforementioned criteria
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start20 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Karwedsky, Study director, Solventum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625385
- Sponsor's protocol ID
- EM-05-015140
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06625385
- Acronym / sponsor ID
- EM-05-015140
- Conditions
- Wound
- Keywords
- Open, Closed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3M™ V.A.C.® Peel and Place Dressing | Experimental | Device: 3M™ V.A.C.® Peel and Place Dressing3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 22 years old at the time of consent.
- Subject or legally authorized representative (LAR) is able to provide informed consent.
- 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:
- Subject is willing and able to attend all study visits.
Key exclusion criteria (30 listed)
- Subject is pregnant or lactating prior to application of the initial dressing. *
- Women who have had surgical sterilization by a medically accepted method (ie, tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing.
- Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
- Subject has been diagnosed with a malignancy in the wound.
- Subject has untreated osteomyelitis or untreated cellulitis in the wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M™ V.A.C.® Peel and Place DressingApplication of 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy | Device | 3M™ V.A.C.® Peel and Place Dressing |
Primary outcome
Incidence of (ADEs)
Time frame: 14 days
The incidence of adverse device effects (ADEs)
4 secondary outcomes
Percentage of closed surgical incisions and skin flaps that remain closed
Time frame: 14 days
Percentage of skin grafts with ≥ 90% graft take
Time frame: 14 days
Percentage of open wounds with evidence of healing
Time frame: 14 days
Overall rate of wound healing for both open wounds and closed/covered wounds
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Karwedsky study director
Solventum
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ V.A.C.® Peel and Place Dressing in people with Wound, run by Solventum US LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Synatschk (346-550-5698, esynatschk@solventum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of (ADEs) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.