Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns

NCT02997592 | Completed

• 1 other identifier: CIP0009
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Partial Thickness Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Dermal safety test (erythema and edema)

  Every time the SpinCare dressing is delivered up to 21 days after initial dressing

• Pain as assessed by VAS

  21 days

• Number of participants having an infection at the burn wound.

  Up to 21 days after initial application of the dressing

• Ease of use

  Every time the SpinCare is used up to 21 days after initial application of the dressing

Study Arms (1)

SpinCare

EXPERIMENTAL

Patients with partial thickness burns treated with the SpinCare System

Device: SpinCare

Interventions

SpinCare DEVICE

The burn wound is treated using the SpinCare Systen

SpinCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanomedic Technologies Ltd.: lead

Study Sites (3)

Rambam Medical Center

Haifa, Israel

Location

Burn Unit, Sheba Medical Center

Ramat Gan, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Study Officials

• Moti Harats, Dr

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 20, 2016
• Study Start: March 20, 2017
• Primary Completion: March 9, 2021
• Study Completion: August 16, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)