Clinical Evaluation of a Novel, Chemically-Generated, Single-Use Negative Pressure Wound Therapy System for the Management of Closed Surgical Incisions.

Background Closed incision negative pressure wound therapy (ciNPWT) is a successful strategy to improve surgical outcomes. However, its use can be limited by the cost of electrically-powered ciNPWT systems, especially in developing countries. A novel negative pressure wound therapy (NPWT) device that utilizes a chemical reaction to create negative pressure promises to be significantly less costly. Method A first-in-human clinical study was completed to evaluate the safety and performance of a novel ciNPWT device (NCT04488666). The primary endpoint was the longevity of the delivery of negative pressure to the wound over seven days. Wound healing was assessed on day seven and day 30. Assessment of the scar quality on day 14 and day 30, exudate management, and ease of use were also undertaken. Results A total of 23 patients were enrolled in the study (mean age 65.0±11.9 years; mean BMI 30.9±6.8 kg/m with a mean wound length of 7.6±2.6 cm, predominantly in elective cutaneous surgery and spinal surgery procedures. The new device was used to maintain negative pressure and manage wound exudate for a mean of 6.3±1.6 days per incision. The mean number of devices used per incision was 1.2±0.5. The Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay as inpatient for a prolonged period (over 14 days) or ASEPSIS and the Patient and Observer Scar Assessment Scale (POSAS) scores indicated overall normal healing and scar quality. There were a total of nine adverse events in five patients. Wounds treated with the new device were not painful. Participant and clinician assessments showed that the devices were easy to use in the hospital and easy to manage at home with routine activities. The device made no audible sound during its use. Conclusion A novel, chemically-generated incisional negative pressure device performed effectively in clinical practice and was shown to be convenient and easy to use. Future studies to assess the effects on surgical site complications are warranted.