Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites (SPINNER01)

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

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

Study Overview

• Status: Completed
• Conditions: Wound of Skin
• Intervention / Treatment: Device: SPINNER; Device: JELONET / IBU Biatain

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Petach Tikva, Israel
    • Beilinson medical center
  • Ramat Gan, Israel
    • Burn Unit, Sheba Medical Center
  • Rehovot, Israel
    • Kaplan Hospital
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPINNER; All patients in this arm will be treated with the SPINNER .	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.
Active Comparator: JELONET or 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.	Device: JELONET / IBU Biatain; The patient's DSW will be dressed by JELONET/IBU Biatain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dermal safety (Draize) score	Change in Draize score from procedure day to day 21	1-21 days
Change in wound healing	Change in wound healing in cm2 from procedure day to day 21	1-21 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanomedic Technologies Ltd.
• Investigators: Principal Investigator: Moti Harats, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Dressing; Nanofibers; Donor site; Polycaprolactone
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CIP0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No