Evaluation of the SpinCare⢠System in the Treatment of Partial Thickness Burns (NCT02997592) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the SpinCare⢠System in the Treatment of Partial Thickness Burns
Israel44 participantsStarted 2017-03-20
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ā„ 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
Exclusion Criteria:
* 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 ā¦