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

Primary Purpose

Wound of Skin

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SPINNER
JELONET / IBU Biatain
Sponsored by
Nanomedic Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Skin focused on measuring Nanofibers, Dressing, Donor site, Polycaprolactone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam Medical Center
  • Beilinson Medical Center
  • Burn Unit, Sheba Medical Center
  • Kaplan Hospital
  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPINNER

JELONET or IBU-Biatain

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in dermal safety (Draize) score
Change in Draize score from procedure day to day 21
Change in wound healing
Change in wound healing in cm2 from procedure day to day 21

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2016
Last Updated
June 12, 2022
Sponsor
Nanomedic Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02680106
Brief Title
Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanomedic Technologies Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Dermal Safety Wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation Study secondary endpoints: Ease of use Pain assessment at 1, 3, 5, 7, 14 and 21 days post operation Infection assessment from 3 days post operation up to 21 days 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin
Keywords
Nanofibers, Dressing, Donor site, Polycaprolactone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPINNER
Arm Type
Experimental
Arm Description
All patients in this arm will be treated with the SPINNER .
Arm Title
JELONET or IBU-Biatain
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SPINNER
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
JELONET / IBU Biatain
Intervention Description
The patient's DSW will be dressed by JELONET/IBU Biatain
Primary Outcome Measure Information:
Title
Change in dermal safety (Draize) score
Description
Change in Draize score from procedure day to day 21
Time Frame
1-21 days
Title
Change in wound healing
Description
Change in wound healing in cm2 from procedure day to day 21
Time Frame
1-21 days
Secondary Outcome Measure Information:
Title
Ease of use
Description
Ease of use will be assessed (questionnaire) by the users whenever the SPINNER is used.
Time Frame
21 days
Title
Assessment of pain
Description
Assessment of pain (VAS scale 0-10) at 1, 3, 5, 7, 14 and 21 days post operation.
Time Frame
21 days
Title
Assessment of infection
Description
Assessment of infection (questionnaire) from 3 days post operation up to 21 days
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moti Harats, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Beilinson Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Burn Unit, Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Kaplan Hospital
City
Rehovot
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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