Incisional Wound Vac in Obese Patients

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00789659

Collaborator

Orthopaedic Trauma Association (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection Postoperative Complication	Other: Negative pressure dressing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Incisional Wound Vac in Obese Patients

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: V.A.C.

Arm

Intervention/Treatment

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 Names:

V.A.C.

Outcome Measures

Primary Outcome Measures

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. [3 days]

Secondary Outcome Measures

The presence or absence of additional procedures needed to gain control of any wound complications. [3 days]
The amount of effluent contained in the V.A.C. canister. [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients between the ages of 18 - 64
Patients with a BMI greater than or equal to 30
Patients with acetabular, pelvic ring, or proximal femur fractures with a degree of displacement that would require an open reduction for treatment under normal circumstances

Exclusion Criteria:

Patients not within variables defined by the inclusion criteria
Abdominal or urological surgery during the same hospital admission
Ipsilateral soft tissue injuries that can be classified as internal degloving injuries