Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
The burn wound is treated using the SpinCare Systen
Rambam Medical Center
Haifa, Israel
Burn Unit, Sheba Medical Center
Ramat Gan, Israel
Sourasky Medical Center
Tel Aviv, Israel
Burn wound healing
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.
Time frame: 21 days
Dermal safety test (erythema and edema)
Dermal safety will be assessed by Draize score including signs of erythema and edema.
Time frame: Every time the SpinCare dressing is delivered up to 21 days after initial dressing
Pain as assessed by VAS
Pain will be assessed at rest, during dressing application (when applicable) and during dressing removal (when applicable) using VAS (Visual Analog Scale) scale.
Time frame: 21 days
Number of participants having an infection at the burn wound.
If infection is suspected clinically, a swab will be taken for microbiological examination and the patient will be treated according to the medical center's standard practice.
Time frame: Up to 21 days after initial application of the dressing
Ease of use
ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).
Time frame: Every time the SpinCare is used up to 21 days after initial application of the dressing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.