Fylladerm Sterile Non-Adherent Dressing 10 X 10 Cm X 10 B

FYLLA derm

NON-ADHERENT DRESSING
WITH NATURAL EXTRACTS

Description Fylladerm is a sterile, non-adherent dressing consisting of an open weave hydrophilic cotton gauze uniformly impregnated with polyethylene glycol based ointment containing natural extracts.
Fylladerm causes an acceleration of tissue regenerative processes, as, thanks to its particular composition, it favors the migration of the cells responsible for the formation of new tissue. The basic principle is to create a barrier effect, which allows the restoration of the optimal conditions for the healing process.
Fylladerm does not adhere to the skin lesion and allows free drainage of the same allowing the passage of exudate to an absorbent secondary dressing. The dressing is well tolerated by the skin, conformable, adaptable and easily applicable.

Features

Composition:
- Support: Hydrophilic cotton gauze with open weave. The warp (96 by 10 cm) and weft (94 by 10 cm) threads are suitably intertwined to minimize fraying, in the event that the dressing is cut into the desired shape.
- Carrier: Polyethylene glycol based ointment.
- Antioxidant: Tocopherol Acetate.
- Natural extracts: Dry extract of Centella Asiatica and Urtica Dioica.

Class of belonging of the product:
Class IIb ; as defined by rule 4 of Annex IX relating to Legislative Decree no. 46 of 24/02/1997 concerning products. and subsequent amendments (Classification Criteria, chapter III), point 1.4 (non-invasive devices in contact with injured skin).

Clinical information

Indications for use
Fylladerm is particularly indicated in the topical treatment of dermal-epidermal tissue alterations that require the reactivation of epithelial neoformation processes, such as: skin wounds, pressure sores, ulcers and burns.

Contraindications
No local or systemic adverse reactions were observed during the clinical study.
Do not use in case of already known sensitivity to the components of the product.

Replacement frequency
The frequency of dressing changes depends on the clinical condition of the skin lesions and varies according to the clinical protocol indicated by the physician.
Fylladerm can be left in place even if the absorbent secondary dressing is changed.

Instructions for Use
Before applying Fylladerm it is necessary to cleanse the affected area.
Remove the dressing from the packaging, then apply gently, in a single layer, directly in contact with the wound surface.
If necessary, cover with an absorbent secondary dressing and secure with a bandage or plaster.

Warnings and Precautions:
In case of sensitization phenomena it is advisable to stop the treatment immediately.
Keep the device out of the reach of children.
After use, do not dispose of the product in the environment.
Do not use if the package is not intact.
Do not leave the dressing in place for longer periods of time than recommended by the clinical protocol.

Sterilization
Sterilized device with beta rays according to a validated cycle that does not alter the characteristics of the product in compliance with the UNI EN ISO 11137 standard. Sterility is valid for 5 years.

Packaging
Each dressing is packaged in a single peel-open pouch.

CODE	SIZE (cm)	DRESSINGS PER PACK
5SVASM520003	10 x 10	10 BAGS