Wound of SkinSPINNER01NCT02680106
Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites
A study testing SPINNER and JELONET / IBU Biatain in people with Wound of Skin, run by Nanomedic Technologies Ltd. at 5 sites in Israel.
Trial summary
Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- SPINNER and JELONET / IBU Biatain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesIsrael
- Study dates
- Feb 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Rambam Medical Center
Haifa
Beilinson Medical Center
Petah Tikva
Burn Unit, Sheba Medical Center
Ramat Gan
Kaplan Hospital
Rehovot
Sourasky Medical Center
Tel Aviv
About this study
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
Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)
Read the 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
- Conditions
- Wound of Skin
- Being tested
- SPINNER, JELONET / IBU Biatain
- Keywords
- Nanofibers, Dressing, Donor site, Polycaprolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
JELONET / IBU BiatainDevice
The patient's DSW will be dressed by JELONET/IBU Biatain
| Study group | Role | What they receive |
|---|---|---|
| SPINNER | Experimental | All patients in this arm will be treated with the SPINNER . Receives: 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. Receives: Device: JELONET / IBU Biatain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dermal safety (Draize) score
Change in Draize score from procedure day to day 21
Measured: 1-21 days
Change in wound healing
Change in wound healing in cm2 from procedure day to day 21
Measured: 1-21 days
Secondary outcomes (3)
Ease of use
Ease of use will be assessed (questionnaire) by the users whenever the SPINNER is used.
Measured: 21 days
Assessment of pain
Assessment of pain (VAS scale 0-10) at 1, 3, 5, 7, 14 and 21 days post operation.
Measured: 21 days
Assessment of infection
Assessment of infection (questionnaire) from 3 days post operation up to 21 days
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanomedic Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moti Harats, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680106
- Sponsor's protocol ID
- CIP0007
- Acronym
- SPINNER01
- Status last verified
- Mar 2019
- First submitted
- 1 Feb 2016
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02680106
- Acronym / sponsor ID
- SPINNER01 / CIP0007
- Conditions
- Wound of Skin
- Keywords
- Nanofibers, Dressing, Donor site, Polycaprolactone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nanomedic Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPINNER | Experimental | Device: SPINNERAll patients in this arm will be treated with the SPINNER . |
| JELONET or IBU-Biatain | Active comparator | Device: JELONET / IBU BiatainAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPINNERThe 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. | Device | SPINNER |
| JELONET / IBU BiatainThe patient's DSW will be dressed by JELONET/IBU Biatain | Device | JELONET or IBU-Biatain |
Primary outcome
Change in dermal safety (Draize) score
Time frame: 1-21 days
Change in Draize score from procedure day to day 21
Change in wound healing
Time frame: 1-21 days
Change in wound healing in cm2 from procedure day to day 21
3 secondary outcomes
Ease of use
Time frame: 21 days
Assessment of pain
Time frame: 21 days
Assessment of infection
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moti Harats, MD principal investigator
Sheba Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPINNER and JELONET / IBU Biatain in people with Wound of Skin, run by Nanomedic Technologies Ltd. at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dermal safety (Draize) score (time frame: 1-21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.