Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-01 @ 3:41 AM
Study NCT ID:
NCT02680106
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites
Sponsor:
Nanomedic Technologies Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPINNER01
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: