NCT00789659

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 10, 2017

Status Verified

April 1, 2012

Enrollment Period

4 years

First QC Date

November 12, 2008

Last Update Submit

February 8, 2017

Conditions

Wound InfectionPostoperative Complication

Keywords

Fracture fixation, internalObesityPelvisNegative pressure wound therapyVacuum-assisted closure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

VAC dressing

EXPERIMENTAL

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

Other: Negative pressure dressing

Interventions

Negative pressure dressingOTHER

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

Also known as: V.A.C.
VAC dressing

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (13)

  • 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.

    PMID: 17519604BACKGROUND

  • 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.

    PMID: 12805398BACKGROUND

  • Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0.

    PMID: 16790384BACKGROUND

  • 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.

    PMID: 15978153BACKGROUND

  • 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.

    PMID: 15995116BACKGROUND

  • 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.

    PMID: 17129369BACKGROUND

  • 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.

    PMID: 15492679BACKGROUND

  • 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.

    PMID: 16799380BACKGROUND

  • 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.

    PMID: 16799379BACKGROUND

  • 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.

    PMID: 15943495BACKGROUND

  • Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.

    PMID: 17106382BACKGROUND

  • 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.

    PMID: 18827587BACKGROUND

  • 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.

    PMID: 18373124BACKGROUND

MeSH Terms

Conditions

Wound InfectionPostoperative ComplicationsObesity

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

InfectionsPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Matthew Graves, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

December 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 10, 2017

Record last verified: 2012-04

Locations

US(1)