ZEVASKYN Cellular sheet Ref.[115567] Active ingredients: Prademagene zamikeracel

2.1 Recommended Dose

For autologous topical application on wounds only.

• The recommended dose of ZEVASKYN is based on the surface area of the wound(s).
• One sheet of ZEVASKYN covers an area of 41.25 cm ².
• Up to twelve ZEVASKYN sheets may be manufactured from the patient biopsies and supplied for potential use.

2.2 Receipt and Preparation

Receipt of ZEVASKYN:

• ZEVASKYN is shipped directly to the qualified treatment center sealed in transport packaging.
• If the patient is expected to be ready for same-day application, transport the packaging to the operating room. Hold at room temperature (15-25°C) until preparation to maintain cell viability.
• If the patient is not expected to be ready for same-day application, store the packaging containing ZEVASKYN in a secure onsite location at room temperature (15-25°C) until preparation to maintain cell viability.

Preparation:

• ZEVASKYN is to be prepared by the manufacturer in an appropriate healthcare setting for surgical application by a qualified healthcare provider.
• Manufacturer will conduct Quality Control (QC) testing to release the product immediately prior to surgery in the operating room.
• Verify patient's identity during preparation.
• Hold ZEVASKYN at room temperature (15-25°C) until application.
• Apply all selected sheets in a single surgical session.

2.3 Administration

Below is the list of standard surgical supplies needed for ZEVASKYN administration and not provided by the manufacturer:

• scalpel
• scissors
• forceps
• resorbable sutures
• non-adhesive dressings
• topical antibiotic ointment

1. Verify patient's identity prior to ZEVASKYN application. Do not apply ZEVASKYN if the information on the patient-specific label(s) does not match the intended patient.

2. Prepare wound by debridement under general or other appropriate anesthesia to accommodate ZEVASKYN sheet(s).

3. Before surgical application, pick up ZEVASKYN sheet with forceps by grasping the titanium ligating clips (Figure 1). Handle ZEVASKYN sheets only with forceps and only by the titanium ligating clips.

Figure 1. ZEVASKYN sheets removed with forceps for application

4. Do not trim ZEVASKYN sheets.

5. Apply unaltered ZEVASKYN sheets onto the wound bed only (nylon suture on the ZEVASKYN sheet facing away from wound) by affixing via resorbable sutures. Do not suture ZEVASKYN onto healthy intact skin. Do not overlap ZEVASKYN sheets on wounds.

6. Apply all selected sheets in a single surgical session.

7. Cover area of application of ZEVASKYN sheets with non-adhesive dressings and topical antibiotic ointment.

After ZEVASKYN application:

8. Instruct patient to leave the treated area undisturbed for 5-10 days at the discretion of the physician based on individual needs for immobilization of treated areas and post-surgical recovery.

9. Instruct patient to keep dressings dry and not submerge the treated area in water until the gauze of the ZEVASKYN product falls off the treatment site. Gauze backing should fall off within 2-3 weeks of ZEVASKYN surgical application.

Store and transport ZEVASKYN at room temperature (15-25°C). ZEVASKYN is stable for 84 hours at room temperature and must be used within 84 hours. Dispose of any compromised or mishandled product.

Dispose of unused ZEVASKYN as surgical biohazardous waste in accordance with local requirements.

Dispose of materials that have come into contact with ZEVASKYN as surgical biohazardous waste in accordance with local requirements.