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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Breast Ptosis
• Intervention / Treatment: Device: V-Loc 180/90 Wound Closure Device; Device: 3-0 Monocryl Absorbable Sutures

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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn
    • Frauenklinik, Bonn, Germany, 53127
      • University Hospital Bonn
  • Stuttgart
    • Boheimstrasse, Stuttgart, Germany, 70199
      • Marien Hospital Stuttgart
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • The Hunstad Center for Cosmetic Plastic Surgery
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Peter Rubin, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 13, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (ESTIMATE): August 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 17, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Mastopexy; Abdominoplasty; Reduction Mammaplasty
• Other Study ID Numbers: SYN08003