Clinical assessment of a simplified single-use NPWT device

A necessary part of research and product development is testing to determine if initial goals are being met. Purpose: To evaluate a prototype of a new device that has been developed to provide NPWT in a radically simplified format. The new simplified single-use NPWT device differs significantly from previous NPWT devices in that it is light weight, operates without an exudate canister. The device is set at -80 mm Hg and is disposable after 7 days.  Methods: A total of 20 patients were recruited into the study from 2 centres. Sixteen (80%) patients had surgical wounds, two (10%) patients had traumatic wounds and two (10%) patients received meshed split thickness skin grafts (STSG). Results: The mean study duration was 10.7 days.  With respect to the performance of the ‘works-like’ prototype pump the vacuum was reported as being maintained in 191 (90.1%) of 212 assessments.  The battery was functioning in 209 (98.6%) of 212 assessments. Discussion: A first use clinical study was performed on a simplified single-use NPWT device.  Patient and clinician satisfaction were high and no new risks were identified. The expected reduced costs, ease of use and increase mobility of patients using this new device, may enable existing NPWT benefits to be available to greater proportion of those patients who would benefit from NPWT. It is hoped that studies of this type will allow for enhanced clinician education, patient safety and prove beneficial to facilities.