Thurs., 10/18/07 Polytrauma, Paper #12, 2:59 pm OTA-2007
Negative-Pressure Wound Therapy following High-Risk Lower Extremity Fractures
James P. Stannard, MD1 (a-Kinetic Concepts, Inc.); David A. Volgas, MD1 (n);
Gerald McGwin III, PhD1 (n); Rena L. Stewart, MD1 (n);
William T. Obremskey, MD2 (a-Kinetic Concepts, Inc.);
Thomas Moore, MD3 (a-Kinetic Concepts, Inc.);
Jeffrey O. Anglen, MD4 (a-Kinetic Concepts, Inc.);
1University of Alabama at Birmingham, Birmingham, Alabama, USA;
2Vanderbilt University, Nashville, Tennessee, USA;
3Emory Healthcare, Atlanta, Georgia, USA;
4Wishard Health Services, Indianapolis, Indiana, USA
Purpose: The purpose of this study is to evaluate the use of negative pressure wound therapy (NPWT) using the vacuum-assisted closure system (VAC, KCI, San Antonio, TX) as a prophylaxis against infection and wound breakdown following high-risk lower extremity fractures.
Methods: This study is a prospective, randomized multicenter clinical trial comparing the use of standard postoperative dressings (group A) and NPWT (group B) following surgical stabilization of calcaneus, pilon, and tibial plateau fractures. Outcome points included wound breakdown (acute and chronic) and infection (acute and chronic). Standard demographic data were also obtained.
Results: 262 patients with 273 fractures have enrolled in this study, with 121 randomized to group A (controls) and 141 to group B (NPWT). There was no difference between the groups in the distribution of calcaneus (36%), pilon (18%), or tibial plateau (44%) fractures. There were five acute infections in group A compared to one in group B. This represents a borderline-significant (P = .09) trend in favor of NPWT. There were 20 delayed (following discharge) infections in group A compared to 13 in group B (P = .09). There were a total of 24 infections in group A and 14 in group B, which represented a significant difference in favor of NPWT (P <0.02). There were a total of 21 cases of some wound dehiscence in group A compared to 12 in Group B, which also represented a significant difference in favor of NPWT (P <0.03). The relative risk of developing an infection was 2.3 times higher in control patients than in patients treated with NPWT.
Conclusions and Significance: NPWT is used as an adjunct to soft-tissue healing in severe wounds following skeletal trauma. There have been no studies evaluating NPWT as a prophylactic treatment to prevent infection and wound dehiscence of high-risk surgical incisions. Our data demonstrate that there is a decreased incidence of wound dehiscence and total infections following high-risk fractures when patients have NPWT applied to their surgical incisions following closure. There is also a borderline-significant trend for decreases in both acute and chronic infections following NPWT. Based on our data in this multicenter prospective randomized clinical trial, NPWT should be considered for high-risk wounds following severe skeletal trauma.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing.