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A Randomized, Controlled Trial Evaluating Negative Pressure Therapy to Reduce Wound Complications Following Major Lower Extremity Amputation
Paul DiMuzio1, *Cara Staley
1, *Federico Biscetti
2, *Dawn Salvatore
1, *Babak Abai
1, *Michael Nooromid
1, *Roberto Aru
1, *Romeo Mateo
3, *Nii-Kabu Kabutey
4, *Ellen Dillavou
51Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania; 2Internal Medicine, Gemelli Hospital, Rome; 3Surgery, West Chester Medical Center, West Chester, New York; 4Surgery, University of California Irvine, Irvine, California; 5Surgery, Wake Forrest University, Raleigh, North Carolina
Objective. Major lower extremity amputation (above- and below-knee) carries a high incidence of incisional complications that compromises prosthesis creation and rehabilitation. Negative pressure therapy (NPT) has been employed successfully in other regions of the body to reduce these complications. This study tests the hypothesis that NPT applied at the time of operation significantly reduces wound healing complications following major amputation.
Methods. In this prospective, multi-center trial, patients undergoing major amputation were randomized (1:1) into receiving NPT versus standard dressing for five days post-operatively. The primary endpoint was any wound complication within 30 days of surgery; secondary endpoints included return to the operating room (OR), readmission, and length of stay. Subgroup analysis was performed to explore the effect of NPT in patients considered to be at high-risk for wound complications (BMI >30, end stage renal disease (ESRD), diabetes, or tissue loss at presentation). Effect estimates were adjusted for site using generalized linear modeling.
Results. A total of 272 participants were randomized; 263 participants were included in the intention to treat analysis (134 NPT patients vs 129 controls). Baseline demographics were similar between the groups (NPT vs control) in terms of mean age (65 vs 64 years), male sex (70% vs 67%), white race (64% vs 66%), mean BMI (23 vs 24), diabetes (69% vs 78%), ESRD (22% vs 19%), and tissue loss (78% vs 75%). The overall 30 day mortality rate was 3.4%. The wound complication rate was similar for those receiving NPT (19%) and controls (23%)(RR 0.80; 95% CI: 0.51, 1.26; P=0.339). The NPT group and controls had comparable outcomes for return to OR (4 vs. 8%, RR 0.83), readmission (9 vs 11%, RR 0.77), and length of stay (10 vs 9.3 days, IRR 1.1). Subgroup analysis showed wound complications for NPT vs controls in 18 vs 27% of obese patients (RR 0.65, CI 0.25-1.64), in 10 vs 28% of non-diabetics (RR 0.36, CI 0.12-1.09), in 23% vs 38% of those with ESRD (RR 0.66, CI 0.27-1.59), and in 3 vs 34% of patients presenting without tissue loss (RR 0.10, CI 0.01-0.74).
Conclusions. Wound complications remain a significant problem following major lower extremity amputation, leading return to the OR, readmission, and significant length of stay. The application of NPT does not appear to reduce the global wound complication rate in this difficult patient population; however, there may be benefit to the selective use of this adjunct in patients who are obese, have ESRD, are non-diabetic and present without tissue loss. In these subgroups, NPT following major amputation should be considered to reduce wound complications.
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