Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study.

Objectives: Surgical site complications following great saphenous vein (GSV) harvest presents a significant risk of morbidity. Negative pressure wound therapy (NPWT) has shown promise in the treatment and prophylaxis of open wounds and surgical incisions but has not been studied following GSV harvest. We performed a feasibility study examining the use of NPWT following GSV harvest for coronary bypass surgery.
Methods: Sixty-four patients were recruited in this single-centre, single-blind, randomized controlled trial. The primary endpoint assessed feasibility by examining rates of device complication and malfunction. Secondary endpoints included rates of surgical site infection, lower leg complications, discharge date, and quality of life at discharge and 6 weeks. NPWT was delivered using the Prevena NPWT device.
Results: There were no complications associated with NPWT which required intervention aside from discontinuation. NPWT was tolerated in 91% (30/33) of patients for the duration of treatment with an average of 4.8 days (±1.45 days). Device malfunction which required discontinuation was 6% (2/33) and involved a malfunctioning pressure sensor and did not affect patient care or present safety concerns. One patient had allergic contact dermatitis to the adhesive and had the device removed. NPWT patients had an earlier date of discharge (6 vs 10 days, P = 0.008), increased ability for self-care ( P = 0.0234) and quality of life ( P = 0.039) at initial assessment, and increased mobility at initial and follow-up assessment ( P = 0.0117 and 0.0123). Conclusions: The use of NPWT following GSV harvest is safe, well tolerated and improves postoperative recovery with prolonged impact on mobility at 6 weeks. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT01698372 ; registration number: NCT01698372.

RCT Entities:   Population Interventions Outcomes