N/A
N=241
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
Breast Ptosis · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00959374 ↗Enrolled (actual)
241
Serious AEs
1.8%
Results posted
Apr 2013
Primary outcome: Primary: Total Dermal Closure Time — 12; 19.2 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- V-Loc 180/90 Wound Closure Device (Device); 3-0 Monocryl Absorbable Sutures (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dermal Closure Time |
12; 19.2 | — |
| SECONDARY Cosmesis |
13.7; 13.6 | — |
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.
Eligibility Criteria
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 > 38ºC), 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 the last 6 months.
- Subject has had a documented breast imaging finding or physical breast exam finding requiring further evaluation prior to elective surgery.
- Subject has not had a mammogram within the last 12 months, for female patients ≥ 40 years of age scheduled for mastopexy or reduction mammaplasty.
- Subject is taking part in another clinical study which directly relates to this study. If, however, the subject is taking part in a non-related study, the investigator should contact the Study Manager for advice.
- The investigator determines that the subject should not be included in the study for reasons not already specified.
Data sourced from ClinicalTrials.gov (NCT00959374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.