Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture

Completed · Not applicable

Conditions studied: Breast Ptosis, Obesity

In brief

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.

Key facts

Study ID

NCT00959374

Run by

Medtronic - MITG

People needed

229

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2013-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwestern University — Chicago, Illinois, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Albany Medical Center — Albany, New York, United States
• University of Rochester — Rochester, New York, United States
• The Hunstad Center for Cosmetic Plastic Surgery — Huntersville, North Carolina, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• University Hospital Bonn — Frauenklinik, Bonn, Germany
• Marien Hospital Stuttgart — Boheimstrasse, Stuttgart, Germany

Full record on ClinicalTrials.gov

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