Suture Granuloma in Body Contouring Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Keywords

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bariatric surgery body contouring skin laxity plastic surgery suture granuloma absorbable sutures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Absorbable sutures

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Donna Doran

Role: STUDY_DIRECTOR

Medtronic - MITG

Locations

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University Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SYN04002

Identifier Type: -

Identifier Source: org_study_id