Partial Thickness Burn Clinical Trial— SPINCARE2
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study
|Other study ID #||CIP0009|
|Start date||March 26, 2017|
|Est. completion date||March 2020|
|Verified date||March 2019|
|Contact||Amnon Gildor, MD|
|Is FDA regulated||No|
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study
|Est. completion date||March 2020|
|Est. primary completion date||March 2020|
|Accepts healthy volunteers||No|
|Age group||18 Years and older|
- Patients = 18 years old at enrolment. Both genders.
- The patient has partial thickness burn wounds (second degree superficial to intermediate) of up to 10% TBSA; of which the target wound for treatment is of up to 5% TBSA or up to 300cm2.
- Presenting at the emergency room within the first 24-48 hours post-injury.
- Patient's wound is defined as a partial thickness burn for conservative treatment (superficial to intermediate second degree).
- Patient underwent cleansing/debridement of initial burn before applying the dressing
- The patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study
- Any known or suspected systemic infection
- Any known sensitivity to components/products used in this study
- Any active, uncontrolled, progressive or untreated malignancy
- Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation
- Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders
- Major dermatological disorders such as: psoriasis, pemphigus, Steven Johnson, etc.
- Patients with burns larger than 10% TBSA
- Patients with burns up to 10% TBSA but no target wound of up to 5% TBSA or up to 300cm2
- Patients suffering from electrical or chemical burns.
- Patients suffering from frostbites.
- Patients suffering from burn wounds that are third degree or full thickness.
- Patients suffering from burn wounds in the head, neck or genital areas
- Female patients who are pregnant or nursing
- Psychiatric patient.
- Participation in another clinical trial within 30 days prior to the Screening Visit
|Israel||Rambam Medical Center||Haifa|
|Israel||Burn Unit, Sheba Medical Center||Ramat Gan|
|Israel||Sourasky Medical Center||Tel Aviv|
|Type||Measure||Description||Time frame||Safety issue|
|Primary||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.||21 days|
|Secondary||Dermal safety test (erythema and edema)||Dermal safety will be assessed by Draize score including signs of erythema and edema in the skin at and around the burn-wound.||Every time the SpinCare dressing is delivered up to 21 days after initial dressing|
|Secondary||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.||21 days|
|Secondary||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 SOPs (Standard Operating Procedures).||Up to 21 days after initial application of the dressing|
|Secondary||Ease of use||ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).||Every time the SpinCare is used up to 21 days after initial application of the dressing|