Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites

Study Overview
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Brief Summary
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Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)

Detailed Description
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The SPINNER is a hand held, portable electro-spinning device that produces personalized in-situ nanofiber dressings for the treatment of external burns and wounds. The dressing has non-adherence, high absorbance, bacterial protection, easy and pain-free peel characteristics and shows excellent conformability and optimal coverage of the wound. The objective of this study is to evaluate the safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW) at size of 10-200 cm2. The study will include five sites in Israel: Sheba Medical Center, Tel Hashomer RambamMedical Center, Haifa Kaplan Medical Center, Rehovot Souraski Medical Center, Tel Aviv Beilinson Medical Center, Petach Tikva Study primary endpoints: Dermal Safety Wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation Study secondary endpoints: Ease of use Pain assessment at 1, 3, 5, 7, 14 and 21 days post operation Infection assessment from 3 days post operation up to 21 days Device related adverse events of the SPINNER device and wound dressing Extended exploratory follow up: Assessment of itching and scarring from wound closure time and up to 12 months follow up

Official Title
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EVALUATION OF THE SPINNER™ DEVICE FOR THE APPLICATION OF WOUND DRESSING: TREATMENT OF SPLIT SKIN-GRAFT DONOR SITES. A Prospective, Safety and Efficacy, Open Labeled, Two Arms, Randomized, Multi Center, Controlled Study

Conditions
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Wound of Skin

Intervention / Treatment
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* Device: SPINNER
* Device: JELONET / IBU Biatain


Participation Criteria
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Eligibility Criteria
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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 prior to the Screening Visit or during this study. Psychiatric patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPINNER<br>All patients in this arm will be treated with the SPINNER . | Device: SPINNER<br>* The SPINNER device is aimed at the DSW from a distance of 20 cm and activated for 1 minute. A nano-fibrous matrix is thus created.<br>|
| Active Comparator: JELONET or IBU-Biatain<br>All patients in this arm will be treated with JELONET/IBU Biatain dressing, regarded as the standard of current care for split-skin donor-site wounds. | Device: JELONET / IBU Biatain<br>* The patient's DSW will be dressed by JELONET/IBU Biatain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dermal safety (Draize) score | Change in Draize score from procedure day to day 21 | 1-21 days | 
| Change in wound healing | Change in wound healing in cm2 from procedure day to day 21 | 1-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Ease of use will be assessed (questionnaire) by the users whenever the SPINNER is used. | 21 days | 
| Assessment of pain | Assessment of pain (VAS scale 0-10) at 1, 3, 5, 7, 14 and 21 days post operation. | 21 days | 
| Assessment of infection | Assessment of infection (questionnaire) from 3 days post operation up to 21 days | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nanofibers, Dressing, Donor site, Polycaprolactone