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| Sponsors and Collaborators: |
University of Mississippi Medical Center Orthopaedic Trauma Association |
|---|---|
| Information provided by: | University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT00789659 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Wound Infection Postoperative Complication |
Other: Negative pressure dressing |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
| Official Title: | Incisional Wound Vac in Obese Patients |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
VAC dressing: Experimental
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Scott E Porter, MD | 6018151950 | sporter@orthopedics.umsmed.edu |
| Contact: George V Russell, MD | 6018151277 | gvrussell@orthopedics.umsmed.edu |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| Principal Investigator: | Scott E Porter, MD | University of Mississippi Medical Center |
More Information
| Responsible Party: | University of Mississippi ( Scott E. Porter, MD/ Assistant Professor of Orthopaedic Surgery ) |
| Study ID Numbers: | 2008-0142 |
| Study First Received: | November 12, 2008 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00789659 |
| Health Authority: | United States: Institutional Review Board |
|
Fracture fixation, internal Obesity Pelvis Negative pressure wound therapy Vacuum-assisted closure |
|
Obesity Postoperative Complications Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Wound Infection |
|
Pathologic Processes Infection |
