Stratagraft
Generic name: allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Dosage form: cellular sheet
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information
Indications and Usage for Stratagraft
Stratagraft is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
Stratagraft Dosage and Administration
Dosage
Stratagraft is for topical application to a prepared wound bed (excision/debridement).
A Stratagraft construct is an approximately 100 cm2 (approximately 8 cm by 12.5 cm) off-white rectangle. A Stratagraft construct may be trimmed to fit the shape and size of the wound area. The surface area of Stratagraft to be applied should be equal to the surface area of the wound to be treated.
Multiple constructs may be applied to cover large wound areas. If multiple constructs are required to cover the wound area, abut the Stratagraft constructs, and it is not necessary to overlap the edges.
Each construct is for application to a single patient only.
Preparation
Stratagraft is to be prepared in an appropriate surgical environment.
Stratagraft is supplied as follows:
The Stratagraft carton contains a laminated foil pouch (Figure 1).
Figure 1: Stratagraft carton and foil pouch
Within the pouch is the Stratagraft Product Dish that contains Stratagraft on a polystyrene insert tray (Figure 2).
Figure 2: Stratagraft Product Dish containing the Stratagraft construct
Inside the Stratagraft Product Dish is the polystyrene insert tray that contains the Stratagraft construct (Figure 3).
Stratagraft is loosely adhered to a polycarbonate membrane contained within a polystyrene insert tray frame.
