A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients

Study Overview
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Brief Summary
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Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin. The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing. The aim of this study is to determine the suitability of this device in RDEB wounds and assess its wound healing properties, safety and tolerability.

Detailed Description
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Investigators will aim to recruit a mixture of adult and pediatric participants. However, the first participant that investigators would recruit would be an adult to ensure investigators have safety and efficacy data before enrolling pediatric participants. Screening- Participants would be screened over the phone to assess if participants meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the participant to review the consent form and sign. Wounds will be assessed to see if participants meet the inclusion and exclusion criteria. Day 0 - A full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound dressings (6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. At the time of matrix application, the investigator will score amount of wound burning, pain, or other adverse events. Non-treated wounds will have the participant's standard of care, non-adhesive bandage applied. Participants and caregivers will be trained on how to use the DORA (RedCAP enabled photo capture system that is PHI compliant). Investigators will aim to capture photos of the wounds using this application weekly. Wound pain and itch are also captured weekly in the app. Day 1 and 2- Clinic Visits: A wound examination will be performed in clinic. Reapplication of matrix treatment may be required depending on how well the matrix has propagated . The investigator will assess the adherence of the matrix, and any adverse events (AEs). Months 1, 2, 3, 4 Home-nurse Visits: Clinic attendance for participants with EB may be stressful and inconvenient due to complex wound pattern and dressing changes. Keeping safety and dignity as a priority investigators will conduct the remaining visits as home nurse visits with telehealth assessments. This will be done over a secure virtual platform whereby the investigators will be consulting remotely from a private Stanford based office room. A home nurse will travel to the participants home to apply the matrix to randomized, treated wounds once a month (additional interim home visits/telehealth assessment and reapplication of matrix treatment may occur at Day 14, month 1.5, month 2.5 and month 3.5 if deemed necessary). Photographs will be taken at those timepoints using DORA, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the home-nurse will score amount of wound burning, pain, or other adverse events. Months 4 Telehealth /End of study Visit: The investigator will virtually assess wound healing compared to baseline photographs in the treated and control wounds. Digital photographs of the treatment and control wounds will be taken with a ruler by the home-nurse and sent to the investigator. All wound photos will be reviewed via DORA.

Official Title
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A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients

Conditions
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Recessive Dystrophic Epidermolysis Bullosa

Intervention / Treatment
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* Device: Spincare matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and genetic diagnosis of RDEB by a dermatologist Age 6 years or older willing and able to give consent/assent At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin) Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks) Exclusion Criteria: Actively infected wounds with pus (colonized wounds are eligible) Wounds that have had squamous cell carcinoma (SCC) Wounds on the face and genitals Wounds that have been treated with investigational therapies in the past 3 months

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control wound<br>standard of care dressing and bandages | |
| Experimental: matrix treated wounds<br>wounds treated with Spincare matrix device at monthly intervals or as required at the discretion of the principal investigator | Device: Spincare matrix<br>* The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of wound closure | comparison of the duration of wound closure (weeks) of matrix treated wounds vs control wounds from baseline to Month 4 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event profile characterization | comparison of application site adverse events (burning, erythema, pain) between matrix treated wounds vs control wounds after application | 4 months | 
| wound pain assessment | comparison of wound pain (Wong-Baker Faces scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The scale consists of six faces that range from no pain at all (favorable outcome) to the worst pain imaginable (worst outcome) | 4 months | 
| wound itch assessment | comparison of wound itch (Itch Man scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The Itch Man scale is used to rate itching intensity and ranges from 0- comfortable, no itch (favorable outcome) to 4- itches most terribly, impossible to sit still, concentrate (worst outcome) | 4 months | 
| caregiver response assessment | comparison of patient and caregiver responses on wound dressing ease of use on matrix treated wounds vs control wounds with the Caregiver Global Impression of Change survey (CrGI). | 4 months | 
| wound microflora assessment | comparison of change in wound cultures between matrix treated wounds vs control wounds at 4 months. | 4 months |