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

NCT00959374 | Completed Results

• 1 other identifier: SYN08003
• Study Type: interventional
• Target: 229
• Locations: 2 countries
• Sites: 8

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.

Conditions

Breast Ptosis; Obesity

Keywords

Abdominoplasty; Reduction Mammaplasty; Mastopexy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cosmesis

  12 weeks

Study Arms (1)

V-loc and Monocryl

ACTIVE COMPARATOR

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; Device: 3-0 Monocryl Absorbable Sutures

Interventions

V-Loc 180/90 Wound Closure Device DEVICE

Barbed absorbable suture

V-loc and Monocryl

3-0 Monocryl Absorbable Sutures DEVICE

3-0 Monocryl Absorbable Suture (non-barbed)

V-loc and Monocryl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (8)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Albany Medical Center

Albany, New York, 12206, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

The Hunstad Center for Cosmetic Plastic Surgery

Huntersville, North Carolina, 28078, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

University Hospital Bonn

Frauenklinik, Bonn, 53127, Germany

Location

Marien Hospital Stuttgart

Boheimstrasse, Stuttgart, 70199, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amy Pollack M.D. Vice President Medical Affairs, STI
• Organization: Covidien

amy.pollack@covidien.com

203-821-4719

Study Officials

• Peter Rubin, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 17, 2013
• Results First Posted: April 17, 2013

Record last verified: 2013-03

Locations

DE (2); US (6)