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Wound Repair and Body Contouring Surgery After Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609037
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):
Kevin Hagan, Vanderbilt University

Brief Summary:
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.

Condition or disease
Obesity, Morbid

Detailed Description:

The morbidly obese patient after successful weight reduction surgery represents a poorly understood patient population that presents unique quandaries. Prior to gastric bypass surgery, many of these patients have Type II diabetes, frequent skin infections from poor hygiene, and multiple medical co-morbidities. Fortunately, numerous problems resolve during the period of the rapid weight loss. Typically the Type II diabetes comes under control without medication and patients experience improvement in mobility and psychosocial adjustment. Unfortunately new dilemmas can rise such as vitamin deficiencies due to many months of starvation, residual end glycosylation products in diabetic skin and massive skin redundancies in multiple locations. Excessive skin is prone to infection. Patients continue to be plagued with postural problems, functional problems (improper personal hygiene, continued difficulties in ambulation) and psychosocial problems associated with a poor body image. Body contouring can provide such patients with marked improvements in lifestyle. The post-bariatric patient population is rapidly increasing in number, yet their wound healing responses to accidental or surgical trauma are unreported in the literature.

Recent studies have documented clinical suspicions that the post-bariatric patient is at an increased risk for wound healing complications following body contouring procedures. The most recent retrospective study of 30 patients

assessed post-surgical outcomes following body contouring procedures in multiple body locations and noted a 20% incidence of wound breakdown and a 16% incidence of seroma (1). An earlier retrospective study comparing panniculectomy in post bariatric patients to those receiving a simultaneous panniculectomy plus gastric bypass documented wound infections (16%), dehiscence (13%) and skin necrosis (6%) in the post bariatric group (2). A prospective study of ten post-bariatric patients who were given a circumferential abdominoplasty likewise experienced wound complications: (33% seromas, 16.6% dehiscence, and infections 8.2%) (3). An 11 patient dermalipectomy series for body contouring after bariatric surgery showed a 27% incidence of infection and seroma (4). To date, the highest rate of wound healing complications was reported in 46 out of 55 (86%) dermolipectomy patients (5). Taken together these reports provide clinical evidence that wound healing is impaired in the post-bariatric patient population. We are prepared to undertake a quantitative evaluation of wound repair characteristics in this select population.

There are multiple reasons to suspect that the skin itself may be defective in these patients who have undergone massive weight reduction. A lifetime of stretched out skin can thin the density of epidermal appendages and peripheral nerve endings, alter the vascular network, diminish the elasticity and alter the weave of the collagen bundles in the reticular dermis. Such negative circumstances may impede the delivery of oxygen and nutrients and ultimately hinder tensile strength. Nutritional deficiencies from the forced starvation are thought to decrease anabolic processes and impair the inflammatory processes, factors that also govern the timing and quality of wound repair. Dehiscence rates could be negatively impacted by this synergy of alterations. While the post-bariatric patients can electively seek body contouring surgery, it is certain that the ever increasing number of post-bariatric patients will experience unexpected trauma or non-elective surgical procedures - all circumstances that also challenge the body to repair itself. We maintain that it will be important to document wound healing deficiencies so that optimal treatment plans can be implemented when the need arises.

Disclaimer: Individuals who participate in this study are financially responsible for all costs relating to the surgery!

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot/Feasibility Study on Wound Repair and Body Contouring Surgery After Gastric By-pass
Study Start Date : January 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Individuals who has had a weight reduction procedure such as gastric bypass and have body contouring surgery to remove the excessive skin due to the weight loss
Normal controls include individuals who schecule to have an abdominoplasty and are within normal for height and weight

Primary Outcome Measures :
  1. Number and type of wound healing complications in the panniculectomy group compared to the control group [ Time Frame: 1,5,14, 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All potential subjects presenting to the plastic surgery practice ages 18-65 will be approached for participation

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

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 identifier (NCT number): NCT00609037

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
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Study Director: Marcia E Spear, MSN Vanderbilt University Medical Center

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Responsible Party: Kevin Hagan, Associate Professor, Vanderbilt University Identifier: NCT00609037     History of Changes
Other Study ID Numbers: 050298
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Kevin Hagan, Vanderbilt University:
Gastric Bypass
Body contouring
Excessive weight loss
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms