Session VI - Basic Science / Injury Prevention / Spine

Sat., 10/10/09 Basic Sci./Injury Prevent./Spine, Paper #72, 11:13 am OTA-2009

Incisional Negative Pressure Wound Therapy as a Treatment for Draining Hematomas: A Prospective Randomized Study

James P. Stannard, MD1 (4, 5A, 7-Medtronic; 4, 7-Synthes; 5A-Osteolign; 7-Kinetic Concepts, Inc., Smith &Nephew);
David A. Volgas, MD1 (7-AO, Pfizer, KCI, Smith & Nephew, Synthes, Wyeth);
Rena L. Stewart, MD1 (5A, 7-Synthes; 7-Kinetic Concepts, Inc., Smith & Nephew, Pfizer, Wyeth);
Jorge E. Alonso, MD2 (5B-Synthes, USA);
1The University of Alabama at Birmingham, Birmingham, Alabama, USA
2The University of South Alabama, Mobile, Alabama, USA

Purpose: The hypothesis of this study was that application of negative-pressure wound therapy (NPWT) using the vacuum-assisted closure (VAC) device (KCI) would improve the sealing of draining wounds and prevent the return to the operating room to evacuate hematomas when compared to a compression dressing.

Methods: This study was a prospective, randomized IRB-approved study of patients with draining hematomas following surgical fixation of fractures. Patients who had significant drainage from their surgical incision 5 days following fracture fixation were eligible for enrollment into the study. After informed consent, they were randomized into 1 of 2 groups using a computer-based randomization scheme. Patients randomized into group A were treated with a compression dressing and assessed for drainage. Patients randomized to group B were treated with NPWT after enrollment and evaluated for drainage. If drainage continued until postoperative day 10, patients in this study were taken back to the operating room for evacuation of the hematoma and cultures.

Results: 93 patients with 96 draining hematomas were randomized, with 58 wounds in group A (control) and 38 wounds in group B (NPWT). Eight patients (14%) in Group A and 5 patients (13.5%) in group B continued to have drainage on postoperative day 10 and were returned to the operating room for evacuation of the hematoma. Of those taken back to the operating room, 5 patients in group A (8.8%) had an infected hematoma compared to only 1 patient (2.7%) in group B. Group A patients continued to drain for a mean of 2.8 days, group B patients for 2.6 days prior to sealing of the hematoma. There was no difference in the likelihood that patients treated with NPWT would require surgical evacuation of the hematoma compared to control patients.

Conclusion: The use of NPWT over draining surgical incisions after 5 days did not result in faster sealing of the incision nor did it decrease the likelihood that patients would require surgical evacuation of the hematoma. There was a trend toward fewer infected hematomas in patients treated with NPWT than in controls.

Disclosure: (n=Respondent answered 'No' to all items indicating no conflicts; 1=Board member/owner/officer/committee appointments; 2=Medical/Orthopaedic Publications; 3=Royalties; 4=Speakers bureau/paid presentations; 5A=Paid consultant or employee; 5B=Unpaid consultant; 6=Research or institutional support from a publisher; 7=Research or institutional support from a company or supplier; 8=Stock or Stock Options; 9=Other financial/material support from a publisher; 10=Other financial/material support from a company or supplier).

• 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. Δ OTA Grant