HYALO 4 START OINTMENT

Sodium Hyaluronate 0.2% + Collagenase

Medical Description

HYALO 4 START is a topical fluid ointment designed for wound-bed preparation and local management of chronic skin ulcers. It combines sodium hyaluronate 0.2% with bacterial collagenase derived from a non-pathogenic strain of Vibrio alginolyticus. The formulation is intended to support the natural wound-healing process while assisting in the enzymatic removal of devitalized/necrotic tissue.

Active Components

1. Sodium Hyaluronate 0.2%

Sodium hyaluronate is the sodium salt of hyaluronic acid, a naturally occurring component of the extracellular matrix and skin. Hyaluronan participates in several stages of tissue repair, including cellular migration, proliferation, inflammation modulation and tissue remodeling. Its hydrophilic properties can help maintain a moist wound environment, which is important for wound-bed management and cellular migration.

2. Collagenase

The product contains bacterial collagenase obtained from a non-pathogenic Vibrio alginolyticus strain, with an activity of not less than 2.0 nkat/g of ointment. Collagenase acts enzymatically on collagen within devitalized tissue, assisting selective enzymatic debridement and preparation of the wound bed.

How HYALO 4 START Works

The formulation combines two complementary actions:

Sodium hyaluronate → Hydration & healing environment

• Helps maintain moisture at the wound surface.
• Supports conditions favorable for tissue repair.
• Participates in processes involved in cell migration, proliferation and tissue regeneration.

Collagenase → Enzymatic wound-bed preparation

• Helps break down collagen-containing devitalized tissue.
• Facilitates removal of necrotic material from the wound bed.
• Supports preparation of the wound for subsequent granulation and healing.

This combination is therefore particularly useful when effective wound-bed preparation is required as part of chronic-wound management.

Indications / Intended Use

HYALO 4 START is intended for the local management of chronic cutaneous ulcers, particularly:

• Pressure ulcers / bedsores
• Vascular leg ulcers
• Diabetic ulcers
• Chronic wounds containing necrotic or devitalized tissue
• Selected difficult-to-heal wounds where enzymatic wound-bed preparation is clinically appropriate.

Clinical evidence supports collagenase as an enzymatic debridement option in chronic wounds, including pressure ulcers and diabetic foot ulcers, although the quality of evidence varies between studies.

A retrospective study specifically evaluating a hyaluronic-acid/collagenase ointment in chronic hard-to-heal wounds reported progressive improvement in wound-bed cleansing and healing outcomes; however, because this was an observational study, its findings should not be interpreted as definitive proof of efficacy.

Suggested Application

For wound care, the general product instructions describe:

1. Cleanse the wound gently according to the healthcare professional's instructions.
2. If the wound is excessively dry, adequate hydration of the wound bed may be necessary.
3. Apply approximately a 2-mm layer of HYALO 4 START over the affected wound surface.
4. The ointment is generally applied once daily, or according to the healthcare professional's recommendation.
5. Cover with an appropriate sterile wound dressing to maintain adequate contact with the wound.
6. Treatment should be reassessed regularly according to wound condition and clinical progress.

Important: The frequency and duration of treatment should be individualized according to wound type, amount of necrotic tissue, exudate, infection status and the healthcare professional's wound-care protocol.

Composition

Each formulation contains:

• Sodium hyaluronate 0.2%
• Collagenase ≥2.0 nkat/g ointment
• Light liquid paraffin
• White petrolatum

The collagenase is obtained from a non-pathogenic Vibrio alginolyticus strain.

Potential Benefits

• Helps prepare the wound bed for healing.
• Supports a moist wound environment.
• Assists enzymatic removal of devitalized/necrotic tissue.
• Supports the natural processes involved in tissue repair.
• May facilitate progression toward a cleaner, healthier wound bed.
• Combines wound hydration with enzymatic debridement in one topical preparation.

Precautions & Warnings

• For external/topical use only.
• Do not use in patients with a known hypersensitivity to any component of the product.
• Avoid unnecessary contact with the eyes and mucous membranes.
• Use under appropriate medical/wound-care supervision for significant chronic wounds.
• Chronic wounds—especially diabetic foot ulcers, pressure ulcers and vascular ulcers—require assessment of the underlying cause and appropriate wound-care management.
• Signs of infection, such as increasing redness, warmth, swelling, purulent discharge, worsening pain, fever or rapidly deteriorating wound condition, require prompt medical assessment.
• Stop use and seek medical advice if significant irritation, hypersensitivity or an unexpected local reaction occurs.
• Keep out of reach of children.

Storage

Store according to the manufacturer's instructions. Available product information indicates storage at temperatures not exceeding 30°C and advises not to freeze the product.

Important Clinical Note

HYALO 4 START should not be considered a substitute for comprehensive wound management. Chronic ulcers may require debridement, infection assessment and treatment, pressure off-loading, vascular assessment, diabetic control, appropriate dressings and management of the underlying disease.

Evidence for hyaluronic-acid wound products is promising in some types of chronic wounds, but the certainty of evidence differs by wound type; a Cochrane review found insufficient evidence to establish superiority for some pressure and diabetic foot-ulcer outcomes.

Patient Disclaimer

This information is provided for educational purposes only and does not replace professional medical advice, diagnosis, or treatment. HYALO 4 START should be used according to the product instructions and/or the advice of a qualified healthcare professional. Chronic, diabetic, vascular, pressure, infected, deep, extensive, or non-healing wounds require professional medical assessment. Do not self-treat a serious or infected wound without appropriate medical supervision.

Key References

• Cochrane Review — Hyaluronic acid dressings/topical agents for chronic wound healing.
• PubMed — Systematic review of collagenase enzymatic debridement in wounds and ulcers.
• PubMed — Systematic review of collagenase for enzymatic debridement.
• PubMed/PMC — Review of hyaluronan and its role in wound healing.
• PubMed/PMC — Clinical evaluation of hyaluronic-acid/collagenase ointment in chronic hard-to-heal wounds.
• Fidia product Instructions for Use — HYALO 4 START composition, indications and application information.