A Prospective Multicenter Follow-up Study to Assess the Performance, Safety, and Efficacy of a Single-Use Negative Pressure Wound Therapy System for Surgically Closed Incision Sites and Skin Grafts

Introduction: Single-use negative pressure wound therapy (sNPWT) systems have been noted to significantly reduce the rate of surgical site infections and wound complications in closed surgical incisions, when compared with conventional dressings. The use of sNPWT in skin grafts has been comparatively limited to date. A 2013 study showed that one such system could achieve comparable clinical results to traditional negative pressure wound therapy, while also reducing the length of inpatient hospital stay and duration of treatment. Ultimately, the use of sNPWT systems will be judged on its ability to increase healing success rates while minimizing risk of complications. To enable these systems to achieve such improved outcomes, they must also be amenable to patients and clinicians alike.

Objectives: A prospective, multicenter study was conducted to assess whether a recently improved sNPWT system was a safe and effective therapy for surgically closed incisions and skin grafts over a 30-day follow-up period. Effectiveness was defined by the ability of the system to deliver consistently negative pressure and handle exudate and by the percentage of skin graft survival at day 14. Clinician and patient satisfaction were also surveyed.

Results: Inclusion is completed; so far, interim results are available for 26 subjects (mean age, 56.8 years; 61.5% male), of whom 21 had closed surgical incisions and five had skin grafts. Twenty-three subjects had completed the 30-day study period. Clinician satisfaction with the sNPWT system’s ability to manage incision/skin graft was 95.8%, with 85.7% reporting it to be superior to other NPWT devices. Patient satisfaction with the sNPWT system’s overall performance was 91.2%.

Conclusion: Results from this interim analysis indicate that this sNPWT system was well accepted by patients and clinicians. Final results will be presented at the congress, also including rates of surgical site infections, complications, percentage graft take, and dressing wear time.