Suture Granuloma in Body Contouring Surgery

Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223132
• Other study ID #: SYN04002
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 24, 2012
• Start date: February 2005
• Est. completion date: April 2007

Study information

• Verified date: October 2012
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck

Intervention

Device:
• Absorbable sutures

Locations

Country	Name	City	State
United States	University Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States,