Randomized Controlled Trial of Incisional Negative Pressure Following High-Risk Direct Anterior Total Hip Arthroplasty.

Abstract

The direct anterior (DA) approach to total hip arthroplasty (THA) is associated with higher rates of surgical site complications (SSCs) compared to other approaches, particularly among high-risk patients. Closed incision negative pressure therapy (ciNPT) is effective in reducing SSCs and surgical site infections (SSIs) in other populations. We asked whether ciNPT could decrease SSCs in high-risk patients undergoing DA THA. This prospective randomized controlled trial (RCT) enrolled high-risk DA THA patients at 3 centers. Patients were offered enrollment if they had previously identified risk factors for SSC: Body mass index (BMI) >30 kg/m², diabetes, active smoking, or before hip surgery. Patients were randomized after closure to either an occlusive (control) dressing or ciNPT dressing for 7 days. All 90-day SSCs were recorded. A priori power analysis demonstrated 116 patients were required to identify a 4.5x relative reduction in SSCs. Chi-square tests were used to evaluate probability of complications. One hundred and twenty two patients enrolled; 120 completed data collection. SSCs occurred in 18.3% (11/60) of control patients compared to 8.3% (5/60) of ciNPT patients (χ² = 2.60, P = .107). SSCs included dehiscence to the subcutaneous level (13) and prolonged drainage (3). Nine control (15.0%) and 2 ciNPT (3.3%) patients met CDC criteria for superficial SSI (χ² = 4.90, P = .027). Fifteen of 16 SSCs resolved with local wound care. One in the ciNPT group required reoperation for acute PJI. Among patients at risk of surgical site complications undergoing DA THA, we identified a significant reduction in superficial SSIs and a trend toward lower overall SSCs with ciNPT.