Device Dossier

Skin semi-occlusive dressing

Device Dossier for Skin semi-occlusive dressing (Skin semi-occlusive dressing, Class IIa, sponsor Stratpharma). ARTG record, intended purpose, GMDN…

Intended purpose

Stratacel is a semi-occlusive wound dressing intended to cover a wound, to provide and support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. Because Stratacel is a gel, it is easily applied to large exposed surface areas and contoured skin, like the face, neck and chest. Stratacel can be used with or without a secondary protective dressing. Stratacel creates a moist wound environment. Stratacel was developed for use as a wound dressing for the repair of damaged or compromised skin following resurfacing procedures such as: • Laser therapy (ablative and non-ablative), including tattoo removal • Dermal abrasion • Chemical peels Stratacel may also be used in conjunction with other adjunctive treatments to improve overall results. Stratacel contains no alcohols, parabens or fragrances and is transparent and odorless. Stratacel is suitable for people with sensitive skin. Stratacel may be used during pregnancy and while breastfeeding

TGA Public Summary