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Incisional Wound Vac in Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Mississippi Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00789659
First received: November 12, 2008
Last updated: April 5, 2012
Last verified: April 2012
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Incisional Wound Vac in Obese Patients

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789659

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Orthopaedic Trauma Association
Investigators
Principal Investigator: Matthew Graves, MD University of Mississippi Medical Center
  More Information

Publications:

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00789659     History of Changes
Other Study ID Numbers: 2008-0142
Study First Received: November 12, 2008
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Fracture fixation, internal
Obesity
Pelvis
Negative pressure wound therapy
Vacuum-assisted closure

Additional relevant MeSH terms:
Postoperative Complications
Wound Infection
Infection
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014