Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin G… (NCT02680106) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites
Israel41 participantsStarted 2016-02
Plain-language summary
Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)
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:
* The patient is ≥ 18 years old at enrolment. Both genders.
* Patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft
* 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
* Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, 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.
* Patients undergoing repeat skin graft harvesting at the same donor site
* Patients with burns of more than 15% TBSA
* Requires immersion hydrotherapy at any time during study participation
* Bleeding disorders
* Skin disorders such as psoriasis, pemphigus, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), pyoderma gangrenosum and other exfoliative disorders
* Terminal patients
* Soldiers
* Prisoners
* Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
* Participation in another clinical trial within 30 days pri…