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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959374
• Other study ID #: SYN08003
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: March 6, 2013
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: February 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Ptosis
• Obesity

Intervention

Device:
• V-Loc 180/90 Wound Closure Device
Barbed absorbable suture
• 3-0 Monocryl Absorbable Sutures
3-0 Monocryl Absorbable Suture (non-barbed)

Locations

Country	Name	City	State
Germany	Marien Hospital Stuttgart	Boheimstrasse	Stuttgart
Germany	University Hospital Bonn	Frauenklinik	Bonn
United States	Albany Medical Center	Albany	New York
United States	Northwestern University	Chicago	Illinois
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 of Rochester	Rochester	New York
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Dermal Closure Time	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.	At time of surgery	No
Secondary	Cosmesis	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).	12 weeks	No