Biomembrane wound healing

INTERACTIVE BIOMEMBRANE MADE OF CRYSTALCELL 77™

Veloderm is a biological polymeric membrane made from cellulose microfibrils obtained using an advanced and patented biotechnological process. This particular type of cellulose, called CRYSTACELL 77™, is characterized by a low polymerization degree and a high level of crystallinity, enabling the product to deliver healing activity with excellent clinical results. When dampened with physiological solution, Veloderm acquires properties of translucency, thickness, flexibility, density and permeability similar to normal human skin. It is particularly permeable to gases, whilst remaining impermeable to water and bacteria. When in direct contact with exudate, Veloderm permeability to water vapour noticeably increases.

After adhering perfectly to the wound bed, Veloderm generates a sealing process which protects the wound from external dirt and germs, reduces pain and creates an ideal microenvironment for granulation and reepithelialization. Veloderm can promote a correct growth of fibroblasts and is therefore ideal to promote rapid and optimal healing in wounds showing a  compromised dermis.

Veloderm detaches automatically from the skin as soon as reepithelialization is completed. When applied to acute wounds, a single application is usually sufficient for the wound to heal, except in particular cases. When applied to chronic wounds, however, more replacements or partial changes of Veloderm may be required if the biomem-brane is damaged or torn, as these types of wound generally require more time to heal properly.

INTENDED USE
Veloderm is a temporary substitute for skin whenever there is a loss of its superficial layers. It is therefore suitable for the treatment of both acute and chronic wounds with loss of substance, such as ulcers or sores of any origin, burns, abrasions, surgical wounds, actinic burns, skin graft donor sites, Lyell’s Syndrome skin lesions, etc. In the case of chronic wounds, the application of Veloderm and/or any other local dressing must be combined, by experienced physicians, with a suitable general and causal therapy based on the prophylaxis and treatment of each specific disease causing the onset of the ulcer.

INDICATIONS

• Acute lesions up to II degree mixed superficial - deep.
• Chronic lesions, showing at least a partial presence of granulation tissue.
• Chronic and acute lesions of any depth, once superficialization is obtained. Veloderm can be applied only after the lesion to be treated has been properly cleansed and if it shows no evidence of active infection.

INSTRUCTIONS FOR USE

1. Veloderm can be applied by medical, nursing or properly trained staff/personnel.
2. Thoroughly disinfect and cleanse the wound, removing any necrotic tissues, debris and slough by carrying out adequate debridement or brushing, according to the characteristics of the lesion (fig.1).
3. Ascertain that wound characteristics correspond to those listed in the “INDICATIONS” section.
4. Carefully remove the biomembrane from its sterile wrapping, avoiding any bacterial contamination. Veloderm biomembrane can be applied on either side (fig.2).
5. Veloderm must be dampened with saline solution (fig.3). NOTE: Veloderm can be either dampened prior to application, or it can be applied dry to a wet wound and then hydrated with saline solution. If the wound to be covered is larger than the size of a Veloderm single biomembrane, it is possible to place two or more biomembranes side by side, taking care to enable the edges to overlap by approx. 0.5–1 cm. Veloderm can also be cut to size using sterile instruments, to produce more accurate shapes to suit the wound or to produce smaller sizes than the sheets in the pack. Once applied, the size of the biomembrane should be larger than the wound. The edges of the biomembrane should extend beyond the edges of the lesion (by about 1-2 cm, depending on the case) in order to guarantee adequate protection.
6. Ensure that the biomembrane adapts and adheres perfectly to the wound bed by gently pressing it with a wet gauze. This operation will also help to eliminate the air between the wound and the biomembrane, which could potentially impede its beneficial interaction with the wound bed. Perfect adhesion to the wound bed is of the utmost importance in order to obtain a good healing result (fig.4).
7. Protection and securing of  Veloderm:
   1. Acute or chronic wounds with absent or low exudate levels: Veloderm’s adhesion to the wound bed can be easily guaranteed by protecting the biomembrane with a light, non-occlusive bandage. Afterwards, on acute wounds, the bandage can be removed if there is no real risk of mechanical trauma and Veloderm can be left in place even if in contact with external environment. On chronic wounds however, Veloderm must be protected with a bandage in all cases (fig.5).
   2. Acute or chronic wounds with moderate exudate levels: Veloderm must be kept in place using a tulle gras or a low or non adherent gauze, followed by the application of a proper non-occlusive bandage (fig.6).
   3. Acute or chronic wounds with significant exudate levels: after the application of Veloderm with a tulle gras or a low or non adherent gauze over it, it is advisable to apply a highly-absorbent secondary dressing on top (e.g. activated charcoal, polyurethane foam, hydrofibre, alginate), followed by a proper non-occlusive bandage (fig.7).
8. Follow-up: subsequent checkups should be scheduled according to exudation amount: 1-3 days in the case of high or moderate exudate, 7-10 days when exudate is scarce or absent. During checkups, Veloderm must be replaced only when the biomembrane is damaged or torn. Otherwise, the biomembrane should be left in situ, eventually replacing the secondary dressing.
9. Veloderm detaches automatically as soon as reepithelialization is complete. The biomembrane must not be torn. On slightly
   exuding acute wounds, one application is generally sufficient to obtain successful healing.
10. Veloderm can be removed (e.g. in case of infection or any other cause) easily and painlessly when fully soaked (by exudate or aline).
11. Never cover Veloderm biomembrane with adhesive devices. In contact with Veloderm the adhesive would impede its semi-permeable properties.