ACTION AND DESCRIPTION

It does not contain any active ingredients, but rather acts through a physical mechanism that increases pressure on the scar and modifies the moisture under the dressing, producing a correct arrangement of the collagen fibers.

COMPOSITION

Polyurethane dressing consisting of two layers: the outer surface is a microporous polyurethane membrane and the inner surface is an adherent acrylic film to facilitate its attachment to the skin.

STORAGE AND EXPIRATION

Store in a cool, dry place (=< 25°C).

CONTRAINDICATIONS

- Do not use on third degree burns.

- Do not use on open, infected wounds, scabs, or over stitches or staples.

- Do not use if the package is open or damaged.

- It is not suitable for patients with dermatological disorders in which the integrity of the skin in the application area is affected.

- Do not use in case of allergy to acrylics or polyurethanes.

- Do not use in newborns.

- Do not use with oxidizing solutions such as hypochlorite or hydrogen peroxide, as they may decompose the polyurethane in the dressing.

INDICATIONS

1. Reduction of hypertrophic or keloid scars.

Trofolastin Scar Reducer can be used to reduce recent or old hypertrophic scars, such as keloids. A scar is the natural result of the wound healing process. It is important to remember that a wound does not become a scar until it is fully healed.

Treatment duration: In some cases, some improvement has been observed after 4 weeks of treatment; however, it is recommended to continue using the dressing for 8 to 10 weeks for best results (see "Precautions and Contraindications").

2. Helps prevent the formation of hypertrophic scars.

Trofolastín Scar Reducer can be applied to new scars to help prevent the formation of hypertrophic scars.

Duration of preventive treatment: In some cases, the follow-up period has been up to 11 months (see “Precautions and contraindications”).

Trofolastín Scar Reducer can be used on old or newly formed scars, such as red or raised scars caused by burns and cuts, general surgery, cosmetic surgery, or traumatic wounds. Because the healing process varies greatly from person to person, doctors or healthcare professionals should decide when to begin treatment with Trofolastín Scar Reducer. It is not recommended to apply the dressing until the wound has healed and the epidermis has recovered.

Trofolastín Scar Reducer protects scars from solar radiation.

Mammary

Trofolastin Breast Scar Reducer has been specially designed for use on scars produced as a result of plastic or reconstructive breast surgery, such as breast augmentation, breast reduction, or breast lifting or modeling (mastopexy). Trofolastin Breast Scar Reducer can be used to reduce recent or old hypertrophic breast scars, or periareolar or "inverted T" keloids due to plastic or reconstructive surgery.

INSTRUCTIONS FOR USE

1. Wash your hands before applying the dressing. Carefully clean and dry the scar area, ensuring that the skin is completely dry and free of any cream, ointment, or oil to facilitate application of the Trofolastin Breast Scar Reducer dressing.

2. Open the sachet and gently separate the protective layers of the long, rectangular dressing. Place the dressing evenly over the inframammary scar, ensuring that no folds form and that all edges are snug against the skin. If the dressing needs to be trimmed to fit before application, the protective layer should not be removed before cutting and it should be made to ensure that it is large enough to adhere to the healthy skin surrounding the scar.

3. Open the sachet and gently separate the protective layers of the short, rectangular dressing. Place the dressing vertically over the scar evenly (from the areola to the inframammary scar), ensuring that no folds form and that all edges are snug against the skin. If the dressing needs to be trimmed to fit before application, the protective layer should not be removed before cutting and it should be ensured that it is large enough to adhere to the healthy skin surrounding the scar.

4. Open the sachet and gently separate the protective layers of the circular dressing. Place the dressing evenly over the periareolar area, ensuring that no folds form and that all edges are secure against the skin. If the dressing needs to be trimmed to fit before application, the protective layer should not be removed before cutting and it should be ensured that it is large enough to adhere to the healthy skin surrounding the scar.

5. Once applied, the Trofolastín Breast Scar Reducer dressing can remain on the skin surface for up to seven days, depending on the type of scar. The dressing is waterproof if applied without creasing and all edges are secured to the surrounding healthy skin. The dressing is for single use only. If the dressing begins to peel off, replace it with a new Trofolastín Scar Reducer dressing.

6. To remove the dressing, gently lift a corner and carefully pull up the edges of the dressing until it separates from the skin.

PRECAUTIONS AND WARNINGS

- Redness may occur. If redness, pain, and/or irritation occur, discontinue use of Trofolastín Scar Reducer and consult a doctor or healthcare professional.
- Single use: once opened, the product should not be reused due to the risk of contamination and infection.
- If repeated long-term use is necessary, clinical evaluation by a physician/healthcare professional is recommended.
- For external use only.