Clinical trial NCT00789659: Incisional Wound Vac in Obese Patients
Official title: Incisional Wound Vac in Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound Infection
Postoperative Complication
Keywords: Fracture fixation, internal
Obesity
Pelvis
Negative pressure wound therapy
Vacuum-assisted closure
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2008-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: The presence or absence of additional procedures needed to gain control of any wound complications.
timeFrame: 3 days
measure: The amount of effluent contained in the V.A.C. canister.
timeFrame: 3 days
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Matthew Graves, MD
role: PRINCIPAL_INVESTIGATOR
References:
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