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

UNLABELLED

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 ( = 0.03), modified EuroQol Derived Single Index scores ( < 0.001), and a reduction in wound volume [median, 47.25-9.75 cm ( = 0.01)]. Image analysis of wounds pretreatment and posttreatment demonstrated increase in granulation tissue surface area [median, 7.6-28.7 cm ( = 0.003)] and decrease in open wound surface area [median, 48.33-33.6 cm ( = 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.