Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT02680106
Brief Summary:
Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)
Detailed Description:
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:
NCT02680106
Study Brief:
Protocol Section:
NCT02680106