Pilot Study to Assess Safety and Usability of the Kyron NPWT System

Abstract

Background: There is an evident need for Negative Pressure Wound Therapy (NPWT) systems specifically designed for use in resource-constrained settings to aid in the treatment of open wounds. Methods: Prospective single-arm interventional pilot study of 14 patients with complex wounds was conducted at Kirtipur Hospital in Kathmandu, Nepal. A novel NPWT device, the Kyron Suction Unit, was used by 4 plastic surgeons. Primary outcomes were ease of use (10-point Likert scale) and device safety (adverse events recorded). Pain (Visual Analogue Scale score), quality of life (modified EuroQol Derived Single Index scores), and wound dimensions were recorded. Results: User ratings on the 10-point Likert scale indicated high confidence and ease of use: median confidence setting up the device of 1.0 [interquartile range (IQR), 1.0; mean 2.3], median confidence maintaining the device of 1.0 (IQR, 1.0; mean, 1.5), and median ease of disassembly of 1.0 (IQR, 1.0; mean, 1.4). Significant improvement in Visual Analogue Scale scores (P = 0.03), modified EuroQol Derived Single Index scores (P < 0.001), and a reduction in wound volume [median, 47.25-9.75 cm3 (P = 0.01)]. Image analysis of wounds pretreatment and posttreatment demonstrated increase in granulation tissue surface area [median, 7.6-28.7 cm2 (P = 0.003)] and decrease in open wound surface area [median, 48.33-33.6 cm2 (P = 0.01)]. Conclusions: The Kyron Suction Unit was safe and easily managed by plastic surgeons. The device design promoted access to NPWT, a therapy proven to reduce healing time and decrease complications for patients with open wounds, in a resource-constrained setting.