Obesity, Morbid Clinical Trial
Official title:
A Pilot/Feasibility Study on Wound Repair and Body Contouring Surgery After Gastric By-pass
Verified date | December 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
The primary aim of our study is to test the hypothesis that wound healing is impaired in the patient who has experienced massive weight reduction following gastric bypass for morbid obesity. Specifically we will document post-surgical local complications and evaluate multiple wound healing parameters in two patient populations in a prospective fashion. The test group will consist of patients who have undergone dramatic weight loss and are much in need of a panniculectomy due to excessive skin redundancy. The control group will consist of patients within normal weight ranges who are seeking an abdominoplasty.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Gastric Bypass or other weight reduction procedure requesting body contouring surgery - Cosmetic abdominoplasty - Be willing to complete study required bloodwork and collection of tissue and fluid samples Exclusion Criteria: - Unable to comply with study requirements |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and type of wound healing complications in the panniculectomy group compared to the control group | 1,5,14, 28 days | No |
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