Clinical assessment of a simplified single-use NPWT device

Background: The purpose of these studies was 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.  The purpose of the study was to validate performance in a clinical setting.

Methods: A total of 20 patients were recruited into the study from 2 centres in South Africa. There were 9 (45%) male and 11 (55%) female patients with a mean age of 55.2 years (range 27-79). The mean BMI was 30.9Kg/m2 (range 21.8 – 44.3).  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.  The mean dressing wear time per individual patient was 4.6 days ranging from 7.7 for patients with no exudate at baseline, to 3.5 days for patients with moderate exudate.  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.