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Suture Granuloma in Body Contouring Surgery

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ClinicalTrials.gov Identifier: NCT00223132
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 25, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : February 2005
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223132


Locations
United States, Pennsylvania
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Medtronic - MITG
Investigators
Study Director: Donna Doran Medtronic - MITG
More Information

ClinicalTrials.gov Identifier: NCT00223132     History of Changes
Other Study ID Numbers: SYN04002
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by Medtronic - MITG:
bariatric surgery
body contouring
skin laxity
plastic surgery
suture granuloma
absorbable sutures

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases