The Effectiveness of Closed-Incision Negative-Pressure Therapy Versus Silver-Impregnated Dressings in Mitigating Surgical Site Complications in High-Risk Patients After Revision Knee Arthroplasty: The PROMISES Randomized Controlled Trial.

ABSTRACT

BACKGROUND: Revision total knee arthroplasty (rTKA) is associated with significant risk of wound-related morbidity. The present study aimed to evaluate the 1) efficacy of closed-incision negative-pressure therapy (ciNPT) vs silver-impregnated antimicrobial dressing (AMD) in mitigating postoperative surgical site complications (SSCs), 2) the effect of ciNPT vs AMD on certain postoperative health utilization parameters, and on 3) patient-reported outcomes (PROs) improvement at 90-day postoperative follow-up. METHODS: This multicenter randomized controlled trial was conducted between December 2017 and August 2019. Patients ≥22 years, at high risk for SSC, and receiving rTKA with full exchange and reimplantation of new prosthetic components or open reduction and internal fixation of periprosthetic fractures were screened for inclusion. Eligible patients were randomized to receive a commercially available ciNPT system or a silver-impregnated AMD (n = 147, each) for minimum of 5-day duration. Primary outcome was the 90-day incidence of SSCs with stratification in accordance with revision type (aseptic/septic). Secondary outcomes were the 90-day health care utilization parameters (readmission, reoperation, dressing changes, and visits) and PROs. RESULTS: Of 294 patients randomized (age 64.9 ± 9.0 years, female 59.6%), 242 (82.0%) patients completed the study (ciNPT n = 124; AMD n = 118). The incidence of 90-day SSCs was lower for the ciNPT cohort (ciNPT 3.4% vs AMD 14.3%; odds ratio (OR) 0.22, 95% confidence interval (0.08, 0.59); P = .0013). Readmission rates (3.4% vs 10.2%, OR 0.30(0.11, 0.86); P = .0208) and mean dressing changes (1.1 ± 0.3 vs 1.3 ± 1.0; P = .0003) were lower with ciNPT. The differences in reoperation rates, number of visits, and PRO improvement between both arms were not statistically significant (P > .05). CONCLUSION: ciNPT is effective in reducing the 90-day postoperative SSCs, readmission, and number of dressing changes after rTKA. Recommending routine implementation would require true-cost analyses.