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

Abstract

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.

Fig. 1.

Kyron Suction Unit technical drawing. The Kyron Suction Unit is an electrically controlled vacuum pump for the delivery of continuous NPWT, created for medical settings that have infrastructure and training limitations.

Fig. 2.

Healing progression, case report 1. A 59-year-old woman status postemergency fasciotomy for acute limb ischemia complicated by compartment syndrome, resulting in a lower extremity post-surgical wound, was treated with NPWT delivered by the Kyron Suction Unit and compatible accessories. After 11 days of treatment, including 2 dressing changes, the wound bed showed complete coverage with granulation tissue. This allowed for the placement of a split-thickness skin graft and discharge home. At follow-up, the patient reported no complications and had returned to her normal daily activities.

Fig. 3.

Healing progression, case report 2. A 25-year-old man with a history of transverse myelitis resulting in paraplegia presented with a sacral pressure ulcer present for 2 months, measuring 10 × 6 × 1 cm. Patient completed 32 days of treatment with the Kyron Suction Unit, at which time the wound was covered with granulation tissue, allowing for closure by split-thickness skin graft.

Fig. 4.

Healing progression, case report 3. A 22-year-old woman suffering from a traumatic wound on the posterior ankle with exposed achilles tendon following a bike accident 46 days prior presented to the hospital for treatment. Patient completed 12 days of treatment with the Kyron Suction Unit after which granulation tissue covered her exposed tendons allowing placement of a split-thickness skin graft.