Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
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.
Device: V-Loc 180/90 Wound Closure Device
Device: 3-0 Monocryl Absorbable Sutures
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized Study to Evaluate Dermal Closure With an Absorbable Barbed Suture (V-Loc 180 Absorbable Wound Closure Device or V-Loc 90 Absorbable Wound Closure Device) as Compared to a Conventional Absorbable Suture|
- Total Dermal Closure Time [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]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.
- Cosmesis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||August 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: V-loc and Monocryl
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.
Device: V-Loc 180/90 Wound Closure Device
Barbed absorbable sutureDevice: 3-0 Monocryl Absorbable Sutures
3-0 Monocryl Absorbable Suture (non-barbed)
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.
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|University of Massachusetts Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, New York|
|Albany Medical Center|
|Albany, New York, United States, 12206|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|The Hunstad Center for Cosmetic Plastic Surgery|
|Huntersville, North Carolina, United States, 28078|
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|University Hospital Bonn|
|Frauenklinik, Bonn, Germany, 53127|
|Marien Hospital Stuttgart|
|Boheimstrasse, Stuttgart, Germany, 70199|
|Principal Investigator:||Peter Rubin, MD||University of Pittsburgh|