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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02997592
Other study ID # CIP0009
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 26, 2017
Est. completion date March 2020

Study information

Verified date March 2019
Source Nicast Ltd.
Contact Amnon Gildor, MD
Phone +972-8-9153001
Email amnon@nicast.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 will include up to 6 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.

20 patients will be enrolled in the study.

Primary 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SpinCare dressing
The burn wound is dressed using the SpinCare wound dressing

Locations

Country Name City State
Israel Rambam Medical Center Haifa
Israel Burn Unit, Sheba Medical Center Ramat Gan
Israel Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Nicast Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 21 days
Secondary Dermal safety test (erythema and edema) Dermal safety will be assessed by Draize score including signs of erythema and edema in the skin at and around the burn-wound. Every time the SpinCare dressing is delivered up to 21 days after initial dressing
Secondary 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. 21 days
Secondary 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 SOPs (Standard Operating Procedures). Up to 21 days after initial application of the dressing
Secondary Ease of use ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS). Every time the SpinCare is used up to 21 days after initial application of the dressing
See also
  Status Clinical Trial Phase
Withdrawn NCT01455480 - Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn Phase 1/Phase 2