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

Wound of Skin Clinical Trial

— SPINNER01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680106
• Other study ID #: CIP0007
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2019
• Source: Nicast Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound of Skin
• Wounds and Injuries

Intervention

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.
• JELONET / IBU Biatain
The patient's DSW will be dressed by JELONET/IBU Biatain

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Beilinson Medical Center	Petach Tikva
Israel	Burn Unit, Sheba Medical Center	Ramat Gan
Israel	Kaplan Hospital	Rehovot
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Nanomedic Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dermal safety (Draize) score	Change in Draize score from procedure day to day 21	1-21 days
Primary	Change in wound healing	Change in wound healing in cm2 from procedure day to day 21	1-21 days
Secondary	Ease of use	Ease of use will be assessed (questionnaire) by the users whenever the SPINNER is used.	21 days
Secondary	Assessment of pain	Assessment of pain (VAS scale 0-10) at 1, 3, 5, 7, 14 and 21 days post operation.	21 days
Secondary	Assessment of infection	Assessment of infection (questionnaire) from 3 days post operation up to 21 days	21 days