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

Not Applicable

Completed

Conditions: Breast Ptosis
Obesity

Interventions: Device: V-Loc 180/90 Wound Closure Device
Device: 3-0 Monocryl Absorbable Sutures

Registration Number: NCT00959374

Lead Sponsor: Medtronic - MITG

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 the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence.

Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 229

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
V-loc and Monocryl	V-Loc 180/90 Wound Closure Device	Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90.
V-loc and Monocryl	3-0 Monocryl Absorbable Sutures	Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90.

Primary Outcome Measures

Name	Time	Method
Total Dermal Closure Time	At time of surgery	In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.

Secondary Outcome Measures

Name	Time	Method
Cosmesis	12 weeks	Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).

Trial Locations

Locations (8): Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Massachusetts Memorial Medical Center
🇺🇸
Worcester, Massachusetts, United States
University of Pittsburgh School of Medicine
🇺🇸
Pittsburgh, Pennsylvania, United States
Marien Hospital Stuttgart
🇩🇪
Boheimstrasse, Stuttgart, Germany
Albany Medical Center
🇺🇸
Albany, New York, United States
The Hunstad Center for Cosmetic Plastic Surgery
🇺🇸
Huntersville, North Carolina, United States
University Hospital Bonn
🇩🇪
Frauenklinik, Bonn, Germany
University of Rochester
🇺🇸
Rochester, New York, United States