Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)
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: 1. Dermal Safety 2. Wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation Study secondary endpoints: 1. Ease of use 2. Pain assessment at 1, 3, 5, 7, 14 and 21 days post operation 3. Infection assessment from 3 days post operation up to 21 days 4. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
The patient's DSW will be dressed by JELONET/IBU Biatain
Rambam Medical Center
Haifa, Israel
Beilinson Medical Center
Petah Tikva, Israel
Burn Unit, Sheba Medical Center
Ramat Gan, Israel
Kaplan Hospital
Rehovot, Israel
Sourasky Medical Center
Change in dermal safety (Draize) score
Change in Draize score from procedure day to day 21
Time frame: 1-21 days
Change in wound healing
Change in wound healing in cm2 from procedure day to day 21
Time frame: 1-21 days
Ease of use
Ease of use will be assessed (questionnaire) by the users whenever the SPINNER is used.
Time frame: 21 days
Assessment of pain
Assessment of pain (VAS scale 0-10) at 1, 3, 5, 7, 14 and 21 days post operation.
Time frame: 21 days
Assessment of infection
Assessment of infection (questionnaire) from 3 days post operation up to 21 days
Time frame: 21 days
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Tel Aviv, Israel