Incisional Negative Pressure Wound Therapy Impacts on Wound Healing Following Lower Extremity Amputation: A Prospective Randomized Controlled Trial
Holly D. Shan*1, Samuel S. Huffman1, Christopher M. Ply1, Ryan Braun1, Stephen Baker2, Jayson Atves2, John Steinberg2, Christopher Attinger2
1Georgetown University School of Medicine, Bethesda , MD; 2Plastic and Reconstructive Surgery, Medstar Georgetown University Hospital, Washington DC,
Non-traumatic lower extremity amputations (LEA) are high-risk operations. Incisional negative-pressure wound therapy (iNPWT) is a device that could mitigate adverse effects post-LEA in the setting of wound healing of closed surgical incisions. Few trials analyze utilizing iNPWT of closed wounds after LEA in comorbid populations. This pilot study that compares iNPWT and standard dressings in patients.
Patients indicated for non-traumatic LEA at a high-volume wound center were randomized to receive iNPWT or a standard dry dressing over incision at conclusion of LEA. Demographics and comorbidities were obtained through chart review: diabetes mellitus type 2 (DM2), HbAlc, peripheral arterial disease (PAD), chronic kidney disease (CKD), end stage renal disease (ESRD). Complications were assessed at 5, 30, 60, and 90-day time points. Data analysis was performed using STATA (StataCorp, College Station, TX) version 17.0 with statistical significance set at p<0.05. Results were reported as (Dry dressing vs. iNPWT).
A total of 108 patients were evenly randomized (n=54); 8 patients were lost to follow-up and removed. Demographics were similar in age (58.92 vs. 57.10 years, p=0.49), BMI ( 28.12 vs. 30.04 kg/m2, p =0.20), and gender (25/51, 29.41% vs. 18/49, 36.73% females). Prevalence of DM2 (74.51% vs. 67.35% p=0.52), CKD (9/51, 17.60% vs. 6/49, 12.24%, p=0.42), ESRD (18/51, 35.29% vs. 10/49, 20.41%, p=0.092) did not differ. The dry dressing group had a higher portion of patients with PAD (30/51, 58.82% vs. 15/49, 30.61%, p=0.005). There were no differences in rates of hematoma, seroma, or maceration between both groups at all three time points. The dry dressing group waited significantly longer to ambulate with a prosthetic (93.2±100.6 vs. 82.09±179.2 days, p=0.031, Î²= -35.4). Multiple regression revealed type of dressing exclusively decreased time to heal (Î²= -17.3, p=0.008).
Patients receiving iNPWT had a shorter time to ambulate and healed faster. We welcome other institutions to explore whether iNPWT can be a promising tool to improve patient care following LEA.
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