search
Back to results

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

Primary Purpose

Partial Thickness Burn

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SpinCare
Sponsored by
Nanomedic Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Thickness Burn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical Center
  • Burn Unit, Sheba Medical Center
  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpinCare

Arm Description

Patients with partial thickness burns treated with the SpinCare System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dermal safety test (erythema and edema)
Dermal safety will be assessed by Draize score including signs of erythema and edema.
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.
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.
Ease of use
ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).

Full Information

First Posted
November 22, 2016
Last Updated
June 12, 2022
Sponsor
Nanomedic Technologies Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02997592
Brief Title
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns
Acronym
SPINCARE2
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanomedic Technologies Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Thickness Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpinCare
Arm Type
Experimental
Arm Description
Patients with partial thickness burns treated with the SpinCare System
Intervention Type
Device
Intervention Name(s)
SpinCare
Intervention Description
The burn wound is treated using the SpinCare Systen
Primary Outcome Measure Information:
Title
Burn wound healing
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Dermal safety test (erythema and edema)
Description
Dermal safety will be assessed by Draize score including signs of erythema and edema.
Time Frame
Every time the SpinCare dressing is delivered up to 21 days after initial dressing
Title
Pain as assessed by VAS
Description
Pain will be assessed at rest, during dressing application (when applicable) and during dressing removal (when applicable) using VAS (Visual Analog Scale) scale.
Time Frame
21 days
Title
Number of participants having an infection at the burn wound.
Description
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.
Time Frame
Up to 21 days after initial application of the dressing
Title
Ease of use
Description
ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).
Time Frame
Every time the SpinCare is used up to 21 days after initial application of the dressing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moti Harats, Dr
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Burn Unit, Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs