Device Dossier

Biatain Ibu Non-Adhesive Foam Dressing - Dressing, high-absorbent, foam/sheet/liquid/powder, non-hydrophilic gel-forming

Device Dossier for Biatain Ibu Non-Adhesive Foam Dressing - Dressing, high-absorbent, foam/sheet/liquid/powder, non-hydrophilic gel-forming…

Intended purpose

Biatain Ibu Non-Adhesive Foam Dressing is intended for moist wound healing and exudate management of painful wounds; and is indicated for a wide range of low to highly exuding wounds including acute wounds such as second degree burns, donor sites, postoperative wounds and traumatic wounds; and chronic wounds such as leg ulcers, pressure ulcers and non-infected diabetic foot ulcers. The dressing may reduce wound pain caused by tissue damage; and is suitable for use in combination with compression therapy. Non-adhesive dressings are suitable for use on fragile skin due to the absence of adhesive.

Functional description

The dressing is a sterile, single use, polyurethane foam dressing which contains ibuprofen (0.5 mg/cm²) homogeneously dispersed throughout the foam. Ibuprofen is released into the wound bed when in contact with wound exudate and may be left in place for up to 7 days. The dressing should not be changed more than twice daily corresponding to a maximum daily use of 2400 cm² and can be used continuously for up to 6 weeks as long as clinically indicated.

TGA Public Summary