Antiseptic solution for wound care and healing HEALER® MEDICAL 500 ml

Detailed information about the product

The wound healing process depends on the stage of wound development and the presence of microorganisms that delay healing regardless of the wound’s origin. In cases of chronic wounds, biofilms often form, further slowing down recovery.

HEALER MEDICAL® antiseptic irrigation solution helps eliminate wound-healing obstacles through effective cleansing. Its mechanism of action is based on the surfactant betaine and the antimicrobial effect of polyhexamethylene biguanide hydrochloride (PHMB). Surfactants do not damage tissue and contribute to efficient removal of microorganisms and biofilms. PHMB is effective against bacteria and fungi without harming granulation tissue, epithelium, or surrounding healthy tissue, and is not systemically absorbed.

The presence of pathogenic microorganisms on the skin and mucosa around wounds may lead to contamination of even visually clean wounds. In a favorable environment, this can trigger inflammation.

HEALER MEDICAL® exhibits a pronounced bactericidal effect against both Gram-positive and Gram-negative, aerobic and anaerobic bacteria, in monocultures and microbial associations, including hospital-acquired antibiotic-resistant strains.

The medical device is effective against:

• Gram-positive bacteria (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae);

• Gram-negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., Neisseria gonorrhoeae);

• Viruses (herpes, HIV, and other lipophilic viruses);

• Fungi (Aspergillus spp., Candida albicans, C. tropicalis, C. krusei, and dermatophytes).

The solution helps prevent wound and burn infections and supports the activation of tissue regeneration processes.

Scope of Application

HEALER MEDICAL® antiseptic wound irrigation solution is intended for the treatment of:

• Acute non-infected and infected wounds, including post-traumatic injuries (abrasions, lacerations, puncture wounds, bite wounds, crush injuries), and postoperative wounds.

• Chronic non-infected and infected wounds, including complex, deep, and hard-to-reach wounds, such as trophic ulcers caused by impaired peripheral arterial and/or venous circulation, diabetic foot ulcers, and pressure sores.

• Thermal and chemical burns of degrees I–II and III.

• Wounds caused by radiation exposure.

• Fistulas and abscesses.

• Pericatheter sites of urinary catheters, PEG/PEJ feeding tubes, and drainage tubes.

• Peristomal skin care.

• Intraoperative wound cleansing and irrigation.

• Wound instillation in combination with negative pressure wound therapy (NPWT).

• Moistening dressings or bandages adhered to the wound prior to removal.

HEALER MEDICAL® antiseptic solution is also recommended for:

• Treating any wound surfaces and postoperative sutures;

• Preparing the wound prior to applying HEALER GEL MEDICAL® (see separate instructions);

• Hygienic and surgical hand disinfection for healthcare personnel;

• Reducing or eliminating unpleasant wound odor.

Method of Application

For optimal results, the wound should be rinsed or treated with a swab thoroughly soaked in HEALER MEDICAL® solution, followed by the application of HEALER GEL MEDICAL® wound healing gel (see separate instructions).
To support faster healing, the wound surface should be carefully cleaned of necrotic tissue, fibrin, and biofilms, which promotes more rapid tissue regeneration.
To reduce the risk of contamination by pathogenic microorganisms, it is recommended to treat the widest possible area of skin or mucosa surrounding the wound.

Gauze pads soaked in HEALER MEDICAL® solution should be left on the wound for at least 15 minutes or until the next dressing change, depending on the clinical situation.
The solution may also be used for irrigation of wound cavities via drainage systems.

If a dressing becomes adherent to the wound surface, it should be thoroughly moistened with HEALER MEDICAL® solution until fully saturated and easily removable. This prevents damage to the wound surface and granulation tissue.

For greater comfort during use, the HEALER MEDICAL® solution may be warmed to body temperature immediately before application.

Usage Restrictions

Currently, there are no reliable clinical data indicating mutagenic or teratogenic effects of the components contained in the HEALER MEDICAL® antiseptic solution.
Since systemic absorption of polyhexamethylene biguanide hydrochloride (PHMB) is negligible, the likelihood of its components entering breast milk is considered low.

The use of HEALER MEDICAL® antiseptic solution during pregnancy, in newborns, and in infants is permitted only when the expected benefit outweighs the potential risk of complications.

Interaction with Other Medicinal Products and Other Forms of Interaction

HEALER MEDICAL® solution should not be mixed with or applied simultaneously with other antiseptics, ointments, oils, surfactants, enzymatic preparations, or similar substances.

Adverse Reactions

In rare cases, mild burning sensations may occur after application of HEALER MEDICAL® solution; these symptoms typically resolve on their own within a few minutes. In exceptional cases, allergic reactions such as urticaria or skin rash may occur.

Contraindications

• if the patient is known or suspected to be allergic to any of the product's components;
• for application to the central nervous system or meninges;
• into the middle or inner ear cavity;
• onto the mucous membrane of the eye;
• on hyaline cartilage or during aseptic joint surgery. If HEALER MEDICAL® solution comes into contact with aseptic cartilage, it should be immediately rinsed with Ringer's solution or normal saline;
• in combination with anionic surfactants;
• in combination with cleaning solutions, ointments, oils, enzymes, etc. — these substances must be thoroughly removed from the wound surface before applying the solution;
• for peritoneal lavage or irrigation;
• avoid contact with the eyes;
• not for infusion or injection use

For external use only.

Composition:

Active ingredient: polyhexamethylene biguanide hydrochloride (PHMB) — 0.15%, surfactant betaine — 0.1%, purified water.

Storage conditions.
Store in a place out of reach of children, protected from light, at a temperature between +2°C and +35°C. The bottle should be tightly closed immediately after use to prevent contamination. During use, the bottle neck must be protected from contamination. Bottles that have come into direct contact with a wound or have otherwise become contaminated must be disposed of.

Shelf life.
3 years from the date of manufacture.