Instructions for cleaning, decontamination and irrigation of acute, chronic and infected skin wounds and first and second degree burns

1. Introduction:

Chronic skin wounds are usually covered with scabs, necrotic tissue, and/or biofilm. These formations are very difficult to remove and can delay normal wound healing. Therefore, it is very important to clean the wounds properly. Applying Prontosan wound gel ensures long-term cleaning and decontamination of the wound bed between dressing changes.

Acute wounds also require proper debridement because they are usually contaminated with foreign bodies and microorganisms. These contaminants can inhibit the normal wound healing process and lead to complications such as infection.

Acute traumatic wounds requiring suturing should be treated with Prontosan Wound Gel after surgery and suturing.

Due to its unique combination of ingredients (i.e. the antimicrobial agent polyhexanide and the surfactant betaine), Prontosan is ideal for preventing biofilm formation.

2. Product description and areas of use:

For cleaning, rinsing, moisturizing and decontaminating:

a) for acute non-infected and infected traumatic wounds (eg lacerations, scratches or stab wounds). If the wounds are sutured, Prontosan® wound gel should be applied to them after surgery.

b) chronic non-infected and infected wounds (especially deep and hard-to-access wounds), including arterial and venous ulcers, diabetic foot ulcers, bedsores);

c) for postoperative wounds;

d) thermal, chemical and radiation burns (degrees I-II).

3. Normal use:

For optimal results, the wound and surrounding skin should be cleaned with Prontosan Wound Wash before treatment with Prontosan Wound Gel (see separate product information leaflet).

The wound bed should be liberally applied with Prontosan wound gel. Wound cavities and pockets should be filled with Prontosan Wound Gel. Before dressing the wound, bandages, gauze, compresses or other wound fillers can be moistened with Prontosan wound gel.

Prontosan wound gel can be kept on the wound until the next dressing change.

Depending on the frequency of dressing changes, different amounts of Prontosan wound gel are applied. To ensure proper wound cleaning and decontamination, the wound surface must be kept moist at all times. The scab is carefully removed and removed by changing the dressings. The gel should be applied frequently enough to remove all necrotic material and scabs and to thoroughly prepare the wound bed.

4. Tissue tolerance and biocompatibility:

Dermatologically tested and rated as non-irritating and well tolerated; painless; does not interfere with granulation and epithelization processes.

5. Side effects:

In very rare cases, a slight burning sensation is felt after applying Prontosan, but it usually disappears after a few minutes. Prontosan may cause allergic reactions such as itching (hives) and rashes (exanthema). Anaphylactic shock has been reported in rare cases (less than 1 in 10,000).

6. Contraindications:

Prontosan should not be used:

a) if the patient is allergic or if it is suspected that he may be allergic to one of the components of the product;

(b) on the central nervous system or meninges;

c) to the middle or inner ear;

d) in the eyes;

e) on hyaline cartilages and aseptic joint operations. If Prontosan gets on aseptic cartilage, it should be flushed immediately with Ringer's or normal saline.

f) together with anionic surfactants;

g) together with cleaning soaps, greases, oils, enzymes, etc. These materials must be carefully removed before use.

7. Restrictions on use:

Pregnancy and lactation: there is no evidence of mutagenic or embryotoxic effects of the product's components. Since there is no systemic reabsorption of polyhexanide, its passage into breast milk is unlikely. However, due to the lack of relevant clinical studies and insufficient clinical experience in the treatment of pregnant and lactating women, Prontosan wound gel should be prescribed to these patients only after thorough medical consultation.

Neonates and infants: Due to insufficient clinical data, Prontosan Wound Gel should be administered to neonates and infants only selectively and under close medical supervision.

8. General safety instructions:

For external use only. Do not use for infusions or injections. Do not swallow.

Do not use damaged bottles. The bottles should be protected from direct sunlight. Keep out of reach of children.

9. Summary/Technical Information:

Prontosan wound gel is a canned product, its shelf life is 8 weeks after opening the bottle. The bottle should be closed immediately after use to prevent contamination. During use, the top of the bottle must be protected from contamination.

DISCLAIMER

This information is provided for your reference only and it is not to be relied upon on its own as instructions for use of this medication. It is not a replacement for and should only be used in conjunction with full consultation with a licensed healthcare professional, the information provided by your pharmacist and the manufacturer of the medication. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Other than liability for death or personal injury arising out of our negligence, we shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise."