Incisional Wound Vac in Obese Patients

NCT ID: NCT00789659

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Wound Infection; Postoperative Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VAC dressing

The patients whose postoperative wound will be dressed with a negative pressure (V.A.C.) dressing.

Group Type: EXPERIMENTAL

Negative pressure dressing

Intervention Type: OTHER

A completely occlusive dressing that is attached to a device that allows a constant negative pressure of 125 mmHg to be generated.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

V.A.C.

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

• Abdominal or urological surgery during the same hospital admission
• Ipsilateral soft tissue injuries that can be classified as internal degloving injuries

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Graves, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 12805398 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Venturi ML, Attinger CE, Mesbahi AN, Hess CL, Graw KS. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) Device: a review. Am J Clin Dermatol. 2005;6(3):185-94. doi: 10.2165/00128071-200506030-00005.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Porter SE, Russell GV, Dews RC, Qin Z, Woodall J Jr, Graves ML. Complications of acetabular fracture surgery in morbidly obese patients. J Orthop Trauma. 2008 Oct;22(9):589-94. doi: 10.1097/BOT.0b013e318188d6c3.

Reference Type: BACKGROUND

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Porter SE, Graves ML, Qin Z, Russell GV. Operative experience of pelvic fractures in the obese. Obes Surg. 2008 Jun;18(6):702-8. doi: 10.1007/s11695-007-9320-y. Epub 2008 Mar 29.

Reference Type: BACKGROUND

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Other Identifiers

2008-0142

Identifier Type: -

Identifier Source: org_study_id