Incisional Wound Vac in Obese Patients
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Incisional Wound Vac in Obese Patients|
- The comparative presence of drainage from the incisional wound treated with VAC therapy and the incisional wound treated with simple dry dressings at postoperative day 3. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- The presence or absence of additional procedures needed to gain control of any wound complications. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- The amount of effluent contained in the V.A.C. canister. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: VAC dressing
The patients whose postoperative wound will be dressed with a negative pressure (V.A.C.) dressing.
Other: Negative pressure dressing
A completely occlusive dressing that is attached to a device that allows a constant negative pressure of 125 mmHg to be generated.
Other Name: V.A.C.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789659
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Matthew Graves, MD||University of Mississippi Medical Center|