Device Dossier

Integra Dermal Regeneration Template single layer - Dressing, occlusive, collagen

Device Dossier for Integra Dermal Regeneration Template single layer - Dressing, occlusive, collagen (Dressing, occlusive, collagen, Class III, sponsor…

Intended purpose

Indicated to add extra thickness where required (to the Integra bi-layer dermal replacement) for the postexcisional treatment of full thickness and partial-thickness injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. It is also indicated for use in reconstruction of postexcisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.

Functional description

A porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate.

TGA Public Summary