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

Not Applicable

Completed

• Conditions: Wound of Skin
• Interventions: Device: JELONET / IBU Biatain; Device: SPINNER

• Registration Number: NCT02680106
• Lead Sponsor: Nanomedic Technologies Ltd.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Primary Completion: 2016-12
• Study Completion: 2017-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JELONET or IBU-Biatain	JELONET / IBU Biatain	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.
SPINNER	SPINNER	All patients in this arm will be treated with the SPINNER .

Primary Outcome Measures

Name	Time	Method
Change in wound healing	1-21 days	Change in wound healing in cm2 from procedure day to day 21
Change in dermal safety (Draize) score	1-21 days	Change in Draize score from procedure day to day 21

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Beilinson Medical Center; 🇮🇱 Petach Tikva, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Kaplan Hospital; 🇮🇱 Rehovot, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Burn Unit, Sheba Medical Center; 🇮🇱 Ramat Gan, Israel