Partial Thickness BurnSPINCARE2NCT02997592
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns
A study testing SpinCare in people with Partial Thickness Burn, run by Nanomedic Technologies Ltd. at 3 sites in Israel.
Trial summary
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Thickness Burn
- What is being tested?
- SpinCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesIsrael
- Study dates
- 20 Mar 2017to 16 Aug 2021
- 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
- Patients ≥ 18 years old at enrolment. Both genders.
- The patient has partial thickness burn wounds (second degree superficial to intermediate) of up to 10% TBSA; of which the target wound for treatment is of up to 5% TBSA or up to 300cm2.
- Presenting at the emergency room within the first 24-48 hours post-injury.
- Patient's wound is defined as a partial thickness burn for conservative treatment (superficial to intermediate second degree).
- Patient underwent cleansing/debridement of initial burn before applying the dressing
- 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
- Any active, uncontrolled, progressive or untreated malignancy
- Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment 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
- Major dermatological disorders such as: psoriasis, pemphigus, Steven Johnson, etc.
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- Patients with burns larger than 10% TBSA
- Patients with burns up to 10% TBSA but no target wound of up to 5% TBSA or up to 300cm2
- Patients suffering from electrical or chemical burns.
- Patients suffering from frostbites.
- Patients suffering from burn wounds that are third degree or full thickness.
- Patients suffering from burn wounds in the head, neck or genital areas
- Female patients who are pregnant or nursing
- Psychiatric patient.
- Soldiers
- Participation in another clinical trial within 30 days prior to the Screening Visit
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Medical Center
Haifa
Burn Unit, Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
About this study
Official title: Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study
Read the detailed description
The SpinCare is an electrospinning portable device intended for the external treatment of burns and wounds. The SpinCare is the first made on the spot, bed side, and completely personalized dressing system; with excellent coverage of all size, shapes and difficult contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates excellent medium for tissue repair and healing.
The objective of this study is to evaluate the performance, safety and efficacy of the SpinCare System in the treatment of superficial to intermediate partial thickness burns.
The study included 3 sites. Adult patients with superficial to intermediate partial thickness burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface Area); with an independent burn of up to 5% TBSA.
A prospective single arm, safety and efficacy, open labeled, multi-center study for the treatment of partial thickness burn wounds not considered for surgery using the SpinCare System.
44 patients enrolled in the study.
Endpoints:
- Wound healing and re-epithelialization on day 21.
- The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
- Ease of use
- At postoperative days 7, 14, 21
- Dermal safety assessed by Draize Score
- Visual estimate of wound healing and re-epithelialization
- Pain
- Infection
- Itching
- Itching and scar quality at 3 and 6 months
- Itching and scar quality at 12 months (optional)
- Device related adverse events
- Conditions
- Partial Thickness Burn
- Being tested
- SpinCare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinCareDevice
The burn wound is treated using the SpinCare Systen
| Study group | Role | What they receive |
|---|---|---|
| SpinCare | Experimental | Patients with partial thickness burns treated with the SpinCare System Receives: Device: SpinCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn wound healing
Wound healing and re-epithelialization on day 21. The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
Measured: 21 days
Secondary outcomes (4)
Dermal safety test (erythema and edema)
Dermal safety will be assessed by Draize score including signs of erythema and edema.
Measured: Every time the SpinCare dressing is delivered up to 21 days after initial dressing
Pain as assessed by VAS
Pain will be assessed at rest, during dressing application (when applicable) and during dressing removal (when applicable) using VAS (Visual Analog Scale) scale.
Measured: 21 days
Number of participants having an infection at the burn wound.
If infection is suspected clinically, a swab will be taken for microbiological examination and the patient will be treated according to the medical center's standard practice.
Measured: Up to 21 days after initial application of the dressing
Ease of use
ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).
Measured: Every time the SpinCare is used up to 21 days after initial application of the dressing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start20 Mar 2017
- Primary completion9 Mar 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness BurnStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanomedic Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moti Harats, Dr, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997592
- Sponsor's protocol ID
- CIP0009
- Acronym
- SPINCARE2
- Status last verified
- Jun 2022
- First submitted
- 22 Nov 2016
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study
- ClinicalTrials.gov ID
- NCT02997592
- Acronym / sponsor ID
- SPINCARE2 / CIP0009
- Conditions
- Partial Thickness Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nanomedic Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 20 Dec 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 the SpinCare™ System in the Treatment of Partial Thickness Burns. A prospective, single arm, safety and efficacy, open labeled multi-center study
Detailed description
The SpinCare is an electrospinning portable device intended for the external treatment of burns and wounds. The SpinCare is the first made on the spot, bed side, and completely personalized dressing system; with excellent coverage of all size, shapes and difficult contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates excellent medium for tissue repair and healing.
The objective of this study is to evaluate the performance, safety and efficacy of the SpinCare System in the treatment of superficial to intermediate partial thickness burns.
The study included 3 sites. Adult patients with superficial to intermediate partial thickness burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface Area); with an independent burn of up to 5% TBSA.
A prospective single arm, safety and efficacy, open labeled, multi-center study for the treatment of partial thickness burn wounds not considered for surgery using the SpinCare System.
44 patients enrolled in the study.
Endpoints:
- Wound healing and re-epithelialization on day 21.
- The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
- Ease of use
- At postoperative days 7, 14, 21
- Dermal safety assessed by Draize Score
- Visual estimate of wound healing and re-epithelialization
- Pain
- Infection
- Itching
- Itching and scar quality at 3 and 6 months
- Itching and scar quality at 12 months (optional)
- Device related adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpinCare | Experimental | Device: SpinCarePatients with partial thickness burns treated with the SpinCare System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years old at enrolment. Both genders.
- The patient has partial thickness burn wounds (second degree superficial to intermediate) of up to 10% TBSA; of which the target wound for treatment is of up to 5% TBSA or up to 300cm2.
- Presenting at the emergency room within the first 24-48 hours post-injury.
- Patient's wound is defined as a partial thickness burn for conservative treatment (superficial to intermediate second degree).
- Patient underwent cleansing/debridement of initial burn before applying the dressing
Key exclusion criteria (16 listed)
- Any known or suspected systemic infection
- Any known sensitivity to components/products used in this study
- Any active, uncontrolled, progressive or untreated malignancy
- Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment 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
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 |
|---|---|---|
| SpinCareThe burn wound is treated using the SpinCare Systen | Device | SpinCare |
Primary outcome
Burn wound healing
Time frame: 21 days
Wound healing and re-epithelialization on day 21. The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
4 secondary outcomes
Dermal safety test (erythema and edema)
Time frame: Every time the SpinCare dressing is delivered up to 21 days after initial dressing
Pain as assessed by VAS
Time frame: 21 days
Number of participants having an infection at the burn wound.
Time frame: Up to 21 days after initial application of the dressing
Ease of use
Time frame: Every time the SpinCare is used up to 21 days after initial application of the dressing
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, Dr principal investigator
Sheba Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpinCare in people with Partial Thickness Burn, run by Nanomedic Technologies Ltd. at 3 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 6 inclusion and 16 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 3 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?
Burn wound healing (time frame: 21 days). 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.