GELASPON

GELASPON Strip 1x1x4 cm gelatin sponge

Product properties

Gelaspon

1. Product description

Gelaspon Strip is made from 100% purified pork gelatine and is intended for use as a resorbable haemostatic sponge for haemostasis in various applications. The product is insoluble in water and completely resorbable. Thanks to its fine-pored structure with many chambers, the product can absorb more than 35 times its own weight in blood and other fluids. The absorption capacity of the Gelaspon Strip depends on its physical size and increases further with increasing gelatine content. It is individually packed in a blister pack, sterilised with gamma radiation and intended for single use.

2. Indications

The Gelaspon Strip is used in various applications to achieve local haemostasis by means of a tamponade effect. It can be used for mild to moderate nosebleeds, after tooth extractions and in the treatment of surface bleeding.

3. Contraindications

Allergies to products of animal origin (pork). Do not use the Gelaspon Strip to close skin incisions, as it may impair wound healing. The Gelaspon Strip must not be used on infected sites without the administration of antibiotics.

4. Side effects

There are no known undesirable effects of the product, provided it is used correctly, as intended and not in excessive amounts.

5. Instructions for use

The Gelaspon Strip can be used dry or soaked with a sterile physiological saline solution. For dry use on a moist wound, cut the strip to the desired size, squeeze it slightly and place it on the bleeding site with light pressure for one to two minutes or until the bleeding stops. If the strip is used moistened on a dry wound, it should first be soaked in sterile physiological saline solution and then squeezed between the fingers to expel the air from the chambers. The strip can then be stored in physiological saline solution until use. Depending on the severity of the bleeding, a second strip can be used to achieve haemostasis. Once the bleeding is under control after applying the strip (or several strips or sponges), the Gelaspon Strip can be left in place. If the nosebleed does not stop even with a second Gelaspon Strip, it is recommended to consult a doctor. Even with secreting wounds, the Gelaspon Strip forms a gel that allows painless and epithelium-friendly dressing changes. Excess material should be removed. Depending on the type of application and surgical site, the resorption time of the strip is between 4 and 6 weeks. In the case of bleeding of the nasal mucosa, for example, the strip liquefies after 2 to 5 days. Cut the strip to the desired shape to fit the nose or oral cavity. Then apply the strip to protect the affected area and prevent wound dressings from sticking and/or to control bleeding by means of a tamponade effect. Remove excess strip material.

Important note!
If the strip has been compressed (either by the manufacturer or the user), it will expand when it absorbs fluids. Excess Gelaspon Strip material should be removed after use if possible. In small children and patients with impaired consciousness, Gelaspon should only be used for nosebleeds on the advice of a doctor.

Warnings

Do not use if the packaging is open or damaged. Opened but unused packaging and contaminated material must be disposed of. The resorbable Gelaspon Strip is intended for single use only and is not suitable for re-sterilisation. The effectiveness of Gelaspon may be reduced in patients treated with anticoagulants (blood thinners).

6. General storage and handling

The product must be stored in its closed outer packaging. Before opening, the sterile packaging must be checked for integrity - only then is the sterile barrier function guaranteed. Do not open the packaging until immediately before use.

Packaging and sterility

The products are sterile packed.

Components of the packaging:

• Outer packaging for storage and transport (secondary packaging).
• Sterile packaging (primary packaging).

The packaging is subject to European and international legislation as well as other applicable standards and meets the corresponding requirements. The packaging protects the product from external influences and ensures its sterility during storage.

Handling of the sterile packaging

Remove the product from the sterile packaging using a suitable aseptic technique.

Sterilisation

Gelaspon is sterilised with gamma radiation.

Storage

Gelaspon Strips must be stored in the outer packaging in a dry place at room temperature. Do not expose to direct sunlight.

This information was last revised in February 2022.

Source: Information from the package leaflet
Status: 02/2023