Device Dossier

PROMOGRAN Protease Modulating Matrix - Dressing, interactive

Device Dossier for PROMOGRAN Protease Modulating Matrix - Dressing, interactive (Biochemically-interactive dressing, Class III, sponsor KCI Medical).…

Intended purpose

Indicated for the management of all wounds healing by secondary intent which are clear of necrotic tissue, including: • Diabetic ulcers • Venous ulcers • Pressure ulcers • Ulcers caused by mixed vascular aetiologies • Traumatic and surgical wounds PROMOGRAN matrix has demonstrated haemostatic properties. PROMOGRAN matrix can be used under compression therapy.

Functional description

PROMOGRAN matrix is a topically applied interactive wound therapy. The product is a sterile, freeze dried composite of oxidised regenerated cellulose (ORC) and collagen. In the presence of exudate the PROMOGRAN matrix transforms into a soft and conformable, biodegradable gel; this allows contact with all areas of the wound.

TGA Public Summary