Incisional Wound Vac in Obese Patients
Primary Purpose
Wound Infection, Postoperative Complication
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure dressing
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection focused on measuring Fracture fixation, internal, Obesity, Pelvis, Negative pressure wound therapy, Vacuum-assisted closure
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
Sites / Locations
- University of Mississippi Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VAC dressing
Arm Description
The patients whose postoperative wound will be dressed with a negative pressure (V.A.C.) dressing.
Outcomes
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.
Secondary Outcome Measures
The presence or absence of additional procedures needed to gain control of any wound complications.
The amount of effluent contained in the V.A.C. canister.
Full Information
NCT ID
NCT00789659
First Posted
November 12, 2008
Last Updated
February 8, 2017
Sponsor
University of Mississippi Medical Center
Collaborators
Orthopaedic Trauma Association
1. Study Identification
Unique Protocol Identification Number
NCT00789659
Brief Title
Incisional Wound Vac in Obese Patients
Official Title
Incisional Wound Vac in Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
PI did not want to go forward with study at this time
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
Orthopaedic Trauma Association
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection, Postoperative Complication
Keywords
Fracture fixation, internal, Obesity, Pelvis, Negative pressure wound therapy, Vacuum-assisted closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAC dressing
Arm Type
Experimental
Arm Description
The patients whose postoperative wound will be dressed with a negative pressure (V.A.C.) dressing.
Intervention Type
Other
Intervention Name(s)
Negative pressure dressing
Other Intervention Name(s)
V.A.C.
Intervention Description
A completely occlusive dressing that is attached to a device that allows a constant negative pressure of 125 mmHg to be generated.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The presence or absence of additional procedures needed to gain control of any wound complications.
Time Frame
3 days
Title
The amount of effluent contained in the V.A.C. canister.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Graves, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17519604
Citation
Baugh N, Zuelzer H, Meador J, Blankenship J. Wound wise: wounds in surgical patients who are obese. Am J Nurs. 2007 Jun;107(6):40-50; quiz 51. doi: 10.1097/01.NAJ.0000271848.07721.24.
Results Reference
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PubMed Identifier
12805398
Citation
Canturk Z, Canturk NZ, Cetinarslan B, Utkan NZ, Tarkun I. Nosocomial infections and obesity in surgical patients. Obes Res. 2003 Jun;11(6):769-75. doi: 10.1038/oby.2003.107.
Results Reference
background
PubMed Identifier
16790384
Citation
Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0.
Results Reference
background
PubMed Identifier
15978153
Citation
Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.
Results Reference
background
PubMed Identifier
15995116
Citation
Karunakar MA, Shah SN, Jerabek S. Body mass index as a predictor of complications after operative treatment of acetabular fractures. J Bone Joint Surg Am. 2005 Jul;87(7):1498-502. doi: 10.2106/JBJS.D.02258.
Results Reference
background
PubMed Identifier
17129369
Citation
Rubin RH. Surgical wound infection: epidemiology, pathogenesis, diagnosis and management. BMC Infect Dis. 2006 Nov 27;6:171. doi: 10.1186/1471-2334-6-171.
Results Reference
background
PubMed Identifier
15492679
Citation
Wilson JA, Clark JJ. Obesity: impediment to postsurgical wound healing. Adv Skin Wound Care. 2004 Oct;17(8):426-35. doi: 10.1097/00129334-200410000-00013.
Results Reference
background
PubMed Identifier
16799380
Citation
Argenta LC, Morykwas MJ, Marks MW, DeFranzo AJ, Molnar JA, David LR. Vacuum-assisted closure: state of clinic art. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):127S-142S. doi: 10.1097/01.prs.0000222551.10793.51.
Results Reference
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PubMed Identifier
16799379
Citation
Morykwas MJ, Simpson J, Punger K, Argenta A, Kremers L, Argenta J. Vacuum-assisted closure: state of basic research and physiologic foundation. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):121S-126S. doi: 10.1097/01.prs.0000225450.12593.12.
Results Reference
background
PubMed Identifier
15943495
Citation
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.
Results Reference
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PubMed Identifier
17106382
Citation
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Results Reference
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PubMed Identifier
18827587
Citation
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.
Results Reference
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PubMed Identifier
18373124
Citation
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.
Results Reference
background
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Incisional Wound Vac in Obese Patients
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