NCT02680106

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Nanomedic Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Wound of Skin

Interventions

Type	Name	Description
DEVICE	SPINNER	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.
DEVICE	JELONET / IBU Biatain	The patient's DSW will be dressed by JELONET/IBU Biatain

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2017-12-31
• First posted: 2016-02-11
• Last updated: 2022-06-15

Locations

5 sites across 1 country: Israel