NCT02680106

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 15, 2022

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

February 1, 2016

Last Update Submit

June 12, 2022

Conditions

Wound of Skin

Keywords

NanofibersDressingDonor sitePolycaprolactone

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Ease of use

    21 days

  • Assessment of pain

    21 days

  • Assessment of infection

    21 days

Study Arms (2)

SPINNER

EXPERIMENTAL

All patients in this arm will be treated with the SPINNER .

Device: SPINNER

JELONET or IBU-Biatain

ACTIVE COMPARATOR

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

Interventions

SPINNERDEVICE

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.

SPINNER
JELONET / IBU BiatainDEVICE

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

JELONET or IBU-Biatain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rambam Medical Center

Haifa, Israel

Location

Beilinson Medical Center

Petah Tikva, Israel

Location

Burn Unit, Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Hospital

Rehovot, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Study Officials

  • Moti Harats, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 31, 2017

Last Updated

June 15, 2022

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(5)