Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns (SPINCARE2)

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

Study Overview

• Status: Completed
• Conditions: Partial Thickness Burn
• Intervention / Treatment: Device: SpinCare

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Ramat Gan, Israel
    • Burn Unit, Sheba Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SpinCare; Patients with partial thickness burns treated with the SpinCare System	Device: SpinCare; The burn wound is treated using the SpinCare Systen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermal safety test (erythema and edema)	Dermal safety will be assessed by Draize score including signs of erythema and edema.	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.	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.	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).	Every time the SpinCare is used up to 21 days after initial application of the dressing

Collaborators and Investigators

• Sponsor: Nanomedic Technologies Ltd.
• Investigators: Principal Investigator: Moti Harats, Dr, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2017
• Primary Completion (ACTUAL): March 9, 2021
• Study Completion (ACTUAL): August 16, 2021

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: CIP0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No