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

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.