NCT02997592

Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns

Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Nanomedic Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study

Detailed description

The SpinCare is an electrospinning portable device intended for the external treatment of burns and wounds. The SpinCare is the first made on the spot, bed side, and completely personalized dressing system; with excellent coverage of all size, shapes and difficult contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates excellent medium for tissue repair and healing. The objective of this study is to evaluate the performance, safety and efficacy of the SpinCare System in the treatment of superficial to intermediate partial thickness burns. The study included 3 sites. Adult patients with superficial to intermediate partial thickness burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface Area); with an independent burn of up to 5% TBSA. A prospective single arm, safety and efficacy, open labeled, multi-center study for the treatment of partial thickness burn wounds not considered for surgery using the SpinCare System. 44 patients enrolled in the study. Endpoints: * Wound healing and re-epithelialization on day 21. * The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist. * Ease of use * At postoperative days 7, 14, 21 * Dermal safety assessed by Draize Score * Visual estimate of wound healing and re-epithelialization * Pain * Infection * Itching * Itching and scar quality at 3 and 6 months * Itching and scar quality at 12 months (optional) * Device related adverse events

Conditions

• Partial Thickness Burn

Interventions

Type	Name	Description
DEVICE	SpinCare	The burn wound is treated using the SpinCare Systen

Timeline

• Start date: 2017-03-20
• Primary completion: 2021-03-09
• Completion: 2021-08-16
• First posted: 2016-12-20
• Last updated: 2022-06-15

Locations

3 sites across 1 country: Israel