Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT00789659
Status:
WITHDRAWN
Last Update Posted:
2017-02-10
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisional Wound Vac in Obese Patients
Sponsor:
University of Mississippi Medical Center
Organization:
Study Overview
Official Title:
Incisional Wound Vac in Obese Patients
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI did not want to go forward with study at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is the belief of the investigators that the current trends in complication rates associated with fixation of pelvic ring injuries and acetabular fractures in the obese are unacceptable. The overwhelming majority of these complications can be attributed to problems with surgical wound healing. The investigators feel that if a cost effective and easily performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma population in order to control a potentially devastating complication, then efforts in discovering such an intervention may prove valuable. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.
Detailed Description:
Obesity has been shown to be an independent risk factor for postoperative surgical infections in a variety of obesity related and non-obesity related surgeries. With the risk of an increasingly more obese society, complication rates that significantly differ based on patients' relative obesity may become increasingly unacceptable. The purpose of the proposed prospective study is to evaluate the role that vacuum assisted closure (VAC) may play in reducing these complication rates. Negative pressure or vacuum assisted closure was first introduced in 1997 as a way to control and potentially treat chronic wounds. Since that time, the indications have exploded to include a variety of chronic and acute wound healing problems. We have anecdotally been using VAC therapy (V.A.C.;KCI, San Antonio, Texas) in an effort to control the postoperative draining that is nearly ubiquitous in our morbidly obese orthopaedic trauma patients. The V.A.C. dressing is applied to the acute postoperative wound and maintained during the immediate postoperative period. Although a novel approach to the use of the V.A.C., this use has been previously reported in the orthopaedic literature as a case series. To our knowledge, there has not been a prospective study evaluating the efficacy of the immediate placement of a V.A.C. dressing on postoperative wound infection rates in the setting of the morbidly obese orthopaedic trauma patient. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: