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.
Investigators will aim to recruit a mixture of adult and pediatric patient. However, the first patient that is recruited would be an adult to collect safety and efficacy data before enrolling pediatric patients. Screening- Patients would be screened over the phone to assess if they meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the patient to review the consent form and sign. Wounds will be assessed to see if they 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 care (at least 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. Reapplication of matrix treatment may be required depending on how well the matrix has propagated. 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 patient's standard of care, non-adhesive bandage applied. Subjects and caregivers will be trained on how take photos. The aim is to capture photos of the wounds, pain and itch scores at least every 2 weeks. Surveys will be completed by the caregiver to see if they notice any difference in the wounds with the spray treatment. This will be completed together with the patient's pain and itch surveys. Day 1 and optional Day 2- Clinic Visits: A wound examination will be performed in clinic. The investigator will assess the adherence of the matrix, and any adverse events (AEs). Day 2 visit may be necessary at the discretion of the investigators especially if any adverse events have occurred. Months 1, 2, 3, 4 Visits: clinic attendance for patients with EB may be stressful and inconvenient due to their complex wound pattern and dressing changes. Keeping their safety and dignity as a priority the remaining visits as home visits are conducted with telehealth assessment. This will be done over a secure virtual platform or phone call whereby the assessors will be consulting remotely from a private Stanford based office room. The caregiver will apply the matrix to randomized, treated wounds (up to once a week application is allowed, the date and reason for reapplication is required)(additional interim visits/telehealth assessment and reapplication of matrix treatment may occur at Week 1, Week 2, Week 6, Week 10 and Week 14 or more frequently if deemed necessary). Patients will be asked to record the date each time the Spincare was applied. Photographs will be taken at those timepoints, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the amount of wound burning, pain, or other adverse events will be scored Month 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 caregiver and sent to the investigator. All wound photos will be reviewed via RedCAP. Wound swabs will be collected from treated and untreated wounds prior to spray treatment and at Month 2 and Month 4. Participants may be offered the choice to complete surveys online and/or upload photos via Stanford RedCap. Open-Label (Extension) Phase: After the completion of the 4-month randomized phase, patients will choose to enroll in an open Open-Label Phase for an additional 4 months. Investigators will conduct remote monitoring on a monthly basis to assess adverse events and wound healing. Participants will complete surveys regarding their pain and itch, offer updates on their medical history, and provide information about concurrent medications. No blood draws, wound cultures and in person visits will be required during the Open-Label Phase.
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.
Discovery Hall Stanford University
Redwood City, California, United States
Number of Wounds With Greater Than 90% Wound Closure at 4 Months
The primary endpoint was comparison of the duration of wound closure of matrix-treated wounds vs control wounds measured as the number of wounds achieving greater than 90% wound closure within 4 months
Time frame: Baseline to month 4 of the randomized phase
Adverse Event Profile Characterization
Comparison of application site adverse events (burning, erythema, pain) between matrix-treated wounds vs control wounds after application. For this outcome, adverse events were collected per wound; events affecting the participant but not the wound are not included.
Time frame: 4-month randomized period followed by 4-month open-label period
Change From Baseline in Wound Pain Scale Score Assessment
Pain was assessed using the Wong-Baker Faces scale (prior to matrix application). The scale consists of six faces that range from 0 (no pain at all, favorable outcome) to 10 (worst pain imaginable, worst outcome). Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score range of 0 (no pain at all) to 10 (worst pain imaginable).
Time frame: months 1, 2, 3, and 4 of the randomized phase
Change in Wound Itch Scale Score Assessment
Wound itch scores were assessed using the Itch NRS (prior to matrix application). The Itch NRS is a numerical rating scale from 0 to 10. Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score of 0 to 10 (higher scores correspond to more pain).
Time frame: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment
Comparison of wounds that reach \>50% healing from baseline in matrix vs control (standard-of-care treated) wounds, per clinician assessment.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Time frame: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment
Comparison of wounds that reach \>70% healing from baseline in matrix-treated vs control wounds, per clinician assessment.
Time frame: months 1, 2, 3, and 4 of the randomized phase