Status:
COMPLETED
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
Lead Sponsor:
Medtronic - MITG
Conditions:
Breast Ptosis
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin. Surgical sutures continue to be t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00959374
Start Date
August 1 2009
End Date
February 1 2012
Last Update
April 17 2013
Active Locations (8)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
3
Albany Medical Center
Albany, New York, United States, 12206
4
University of Rochester
Rochester, New York, United States, 14642