Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absor… (NCT00959374) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
United States229 participantsStarted 2009-08
Plain-language summary
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be 18 years of age or older.
* Subject must be in good overall health.
* Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants.
* Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.
Exclusion Criteria:
* Subject is pregnant or breast-feeding.
* Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing.
* Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side.
* Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone.
* Subject has a BMI ≥ 40.
* Subject has diabetes requiring medication for glycemic control.
* Subject has a fever (temperature \> 38ÂşC), active skin infection or systemic infection at the time of surgery.
* Subject underwent chemotherapy or radiation within the last 6 months.
* Subject has a history of keloid or hypertrophic scar formation or other dermatologic conditions known to impair wound healing.
* Subject has a history of alcohol or drug abuse within 6 months prior to screening.
* Subject has a history of immunosuppressive drug use, including steroids, within t…