A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing
ConditionWound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSolventum US LLC
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is at least 22 years old at the time of consent.
Subject or legally authorized representative (LAR) is able to provide informed consent.
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)
Disqualifiers
Subject is pregnant or lactating prior to application of the initial dressing. *
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.
Trial design
Design model
Single group
Treatments tested in this trial
3M™ V.A.C.® Peel and Place Dressing
DeviceApplication of 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: 3M™ V.A.C.® Peel and Place DressingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of (ADEs)
The incidence of adverse device effects (ADEs)
Time frame
14 daysSecondary outcomes
1
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
Time frame
14 days2
Percentage of skin grafts with ≥ 90% graft take
The percentage of skin grafts with ≥ 90% graft take at the end of treatment
Time frame
14 days3
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
Time frame
14 days4
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
Time frame
14 daysOther outcomes
1
Pain score associated with dressing removal
The pain score associated with dressing removal (ie, during dressing changes and at final dressing removal) - Subject-reported and based on the highest level of perceived pain. Whereby a score of 0 is indicative of "no pain" and a score of 10 indicates the "worst pain possible".
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov