Obesity, MorbidNCT00609037
Wound Repair and Body Contouring Surgery After Gastric Bypass
An observational study of Obesity, Morbid, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All potential subjects presenting to the plastic surgery practice ages 18-65 will be approached for participation
Who may be able to join
- 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
Who cannot join
- Unable to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Pilot/Feasibility Study on Wound Repair and Body Contouring Surgery After Gastric By-pass
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.
Read the 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!
- Conditions
- Obesity, Morbid
- Keywords
- Gastric Bypass, Body contouring, Excessive weight loss
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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 | |
| 2 | Normal controls include individuals who schecule to have an abdominoplasty and are within normal for height and weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of wound healing complications in the panniculectomy group compared to the control group
Measured: 1,5,14, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Hagan, Vanderbilt University
- Investigators
- Marcia E Spear, MSN, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609037
- Sponsor's protocol ID
- 050298
- Status last verified
- Dec 2015
- First submitted
- 25 Jan 2008
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot/Feasibility Study on Wound Repair and Body Contouring Surgery After Gastric By-pass
- ClinicalTrials.gov ID
- NCT00609037
- Acronym / sponsor ID
- 050298
- Conditions
- Obesity, Morbid
- Keywords
- Gastric Bypass, Body contouring, Excessive weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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!
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –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 |
| 2 | – | –Normal controls include individuals who schecule to have an abdominoplasty and are within normal for height and weight |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All potential subjects presenting to the plastic surgery practice ages 18-65 will be approached for participation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to comply with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and type of wound healing complications in the panniculectomy group compared to the control group
Time frame: 1,5,14, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia E Spear, MSN study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of wound healing complications in the panniculectomy group compared to the control group (time frame: 1,5,14, 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.