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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00959374
First received: August 13, 2009
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Breast Ptosis
Obesity
Device: V-Loc 180/90 Wound Closure Device
Device: 3-0 Monocryl Absorbable Sutures

Study Type: Interventional
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

Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 229
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 suture
Device: 3-0 Monocryl Absorbable Sutures
3-0 Monocryl Absorbable Suture (non-barbed)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959374

Locations
United States, Illinois
Northwestern University
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
Germany
University Hospital Bonn
Frauenklinik, Bonn, Germany, 53127
Marien Hospital Stuttgart
Boheimstrasse, Stuttgart, Germany, 70199
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Peter Rubin, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00959374     History of Changes
Other Study ID Numbers: SYN08003
Study First Received: August 13, 2009
Results First Received: August 29, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Covidien:
Abdominoplasty
Reduction Mammaplasty
Mastopexy

ClinicalTrials.gov processed this record on September 18, 2014