Suture Granuloma in Body Contouring Surgery

This study has been completed.
Information provided by:
Covidien Identifier:
First received: September 13, 2005
Last updated: October 24, 2012
Last verified: October 2012

The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.

Condition Intervention Phase
Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck
Device: Absorbable sutures
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Covidien:

Study Start Date: February 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. Consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. Patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck.

A major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. Long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. While absorbable sutures are preferred, they can result in suture granuloma and extrusion.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Men and women 18 years and older

Exclusion Criteria:

Subjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side Subjects who cancel their surgery

  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 identifier: NCT00223132

United States, Pennsylvania
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Study Director: Donna Doran Covidien
  More Information

No publications provided Identifier: NCT00223132     History of Changes
Other Study ID Numbers: SYN04002
Study First Received: September 13, 2005
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
bariatric surgery
body contouring
skin laxity
plastic surgery
suture granuloma
absorbable sutures processed this record on March 30, 2015