HEALER® GEL MEDICAL sterile dressing for burns and wounds, impregnated with antiseptic gel

Detailed information about the product

Sterile covering for burns and wounds, impregnated with an antiseptic gel containing polyhexamethylene biguanide hydrochloride (PHMB) and the surfactant betaine, is intended for protection and local action on damaged skin.

The non-woven cellulose material impregnated with gel is elastic, adapts well to the surface of the wound and is well fixed with external dressing material. It does not adhere to the wound surface and is easily and painlessly removed during dressing changes. The covering has high tear strength, creates a barrier against the penetration of bacteria and microparticles from outside, quickly absorbs exudate and bacterial toxins, maintaining a stable moist environment in the wound.

Due to the moistening of the wound surface, oxygen diffusion improves, pain and the risk of infection decrease. The covering maintains normal osmotic pressure of cells, prevents tissue drying, promotes autolytic wound cleansing, activation of granulation tissue and epithelialization processes.

The sterile covering impregnated with antiseptic gel HEALER GEL MEDICAL® has a pronounced bactericidal effect against a wide spectrum of microorganisms, including gram-positive and gram-negative, aerobic and anaerobic bacteria, both in the form of monocultures and as part of microbial associations.

The product is effective against clinically significant pathogens, including: gram-positive bacteria: Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae; gram-negative bacteria: Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., Neisseria gonorrhoeae; hospital strains resistant to antibiotics (MRSA, MDR P. aeruginosa, A. baumannii, etc.).

The medical device helps prevent infection of wounds and burn surfaces, suppresses the growth of pathogenic microflora and creates conditions favorable for the regeneration of damaged tissues.

Scope of application

The sterile dressing for burns and wounds, impregnated with HEALER GEL MEDICAL® antiseptic gel, is recommended for use in the following purposes:

• Local infection control
• Creation and maintenance of an optimally moist wound environment
• Acceleration of reparative processes (granulation and epithelialization)
• Reduction of microbial load and prevention of infection-related complications

The dressing is effective in the following clinical cases:

• Chronic wounds with fibrin coating or necrotic tissue
• Delayed epithelialization after surgical interventions
• Infected and colonized superficial or deep skin lesions
• Areas around stomas, catheters, drainage tubes, punctures, or injection sites
• Thermal and chemical burns of degrees I–II, as well as degree III — during wound cleansing, preparation for surgical treatment, or postoperative healing phase
• Postoperative wounds
• Traumatic skin injuries (cuts, lacerations, contusions)
• Chronic leg ulcers (venous, arterial, or mixed origin)
• Diabetic foot ulcers
• Pressure ulcers of stages I–III

The dressing can be used both in inpatient settings — including departments of surgery, traumatology, burn care, geriatrics, and intensive care — and in outpatient and home settings, as prescribed and under the supervision of a healthcare professional.

Instructions for use

Before applying the dressing, the wound surface should be thoroughly rinsed with HEALER MEDICAL® solution or treated with a gauze pad generously soaked in HEALER MEDICAL® solution (refer to the instructions for use of HEALER MEDICAL® wound solution). To reduce the risk of introducing pathogenic microorganisms into the wound, it is recommended to cleanse the largest possible area of skin or mucosa surrounding the wound.

The wound rinsed with the solution — or gauze pads soaked in HEALER MEDICAL® solution — may be left on the wound for 15 minutes. After that, the sterile dressing for burns and wounds, impregnated with HEALER GEL MEDICAL® antiseptic gel, is applied directly to the wound.

The size of the dressing should exceed the affected area by 2–3 cm on all sides. It should be secured in place with a bandage or any other appropriate dressing material.

One dressing should not remain on the wound for more than 24 hours. Reapplication should be performed daily or more frequently, depending on the level of moisture, dressing condition, amount of exudate, and clinical progress of wound healing.
If the dressing has dried out, it must be pre-moistened with a sterile gauze pad soaked in HEALER MEDICAL® solution or physiological saline to avoid damage to the wound surface during removal.

Before each new application, the wound and surrounding tissue should be re-treated with HEALER MEDICAL® antiseptic solution, in accordance with its instructions for use.

General precautions

The sterile dressing for burns and wounds, impregnated with HEALER GEL MEDICAL® antiseptic gel, is intended for external use only, in accordance with the instructions.
The product is not intended for ophthalmic use, or for intravaginal, rectal, intraoperative, or intracavitary administration.

Use is not recommended in individuals with known hypersensitivity to any of the gel components, including polyhexamethylene biguanide hydrochloride (PHMB), betaine, or auxiliary substances.

In case the gel comes into contact with mucous membranes of the eye, rinse thoroughly with plenty of water. If symptoms of irritation occur (redness, burning, tearing), seek medical attention.

Do not apply the dressing to cartilaginous structures (such as the outer ear or nose), open joints, tendons, or areas with poor vascularization without prior clinical assessment.

It is not recommended to apply the dressing to the same area continuously for more than 7 days, in order to avoid impaired drainage or excessive moisture accumulation. The dressing must not remain on the wound for more than 24 hours without replacement.

This product is intended for single use only. Reuse, even after brief contact with the wound surface, is strictly prohibited due to the risk of secondary infection.

Side effects

In some cases, after applying the sterile dressing for burns and wounds, impregnated with HEALER GEL MEDICAL® antiseptic gel, a temporary sensation of burning or tingling may occur in the wound area. These sensations are typically transient and resolve on their own within a few minutes, without the need to discontinue use.

In rare cases, hypersensitivity reactions to the components of the product may develop. These may present as: itching (urticaria), redness, rash (exanthema).

Composition

Active ingredients: Polyhexamethylene biguanide hydrochloride (PHMB) 0.1%, surfactant betaine 0.1%, hydroxyethyl cellulose, nonwoven cellulose material, osmotic water.

Storage conditions

Store the product in a dry place, protected from direct sunlight, at a temperature between +2°C and +35°C. Keep out of reach of children. Do not freeze. Do not use after the expiration date or if the packaging is damaged.

Shelf Life

3 years from the date of manufacture, provided that the recommended storage conditions are observed.