SYLKE® Skin Closure is a single use, sterile, woven silk mesh coated with a long lasting, pressure sensitive adhesive.

Each sterile wound closure is provided in an individually packaged pouch, with a liner covering the adhesive until the wound closure is ready for use. Each wound closure is provided as a 2.5cm by 32cm, 2.5cm by 16cm, 3.4cm by 24cm strip, allowing use on a variety of wound lengths and for any excess to be trimmed away.

SYLKE® Skin Closure is a sterile, single-use silk mesh strip with pressure sensitive adhesive intended to approximate and secure the edges of clean, superficial skin wounds (e.g. simple lacerations, cuts, puncture wounds post-surgical incisions.). It provides a breathable, sterile barrier that supports natural healing. The strip can be used alone or with sutures, may be applied by consumers or healthcare professionals in home or clinical settings, and is designed to remain in place for up to 14 days while tolerating normal bathing.

SYLKE® Skin Closure is indicated for topical closure and coverage of thoroughly cleansed simple lacerations, cuts, puncture wounds, and post-surgical skin incisions (including those with subcutaneous or dermal sutures), to assist in bringing together skin edges and protecting the wound during the initial healing period.

• SYLKE® Skin Closure is contraindicated for use on infected wounds. Signs of infection may include: pus, pain, warmth, redness, swelling, and/or fever. If any signs of infection are present, seek medical attention.
• SYLKE® Skin Closure is contraindicated for use on dirty wounds. Wounds must be thoroughly cleansed and free of dirt, debris, and any foreign objects prior to application.
• SYLKE® Skin Closure is contraindicated for use in high-tension wounds without the support of additional skin closure devices i.e. sutures.
• SYLKE® Skin Closure is contraindicated for use on wounds that are actively bleeding.

• Do not use SYLKE® Skin Closure on areas where adhesion cannot be obtained. Potential causes of inadequate adhesion are presence of exudate, skin oils, moisture, or areas containing dense hair such as the scalp.
• Do not use SYLKE® Skin Closure on mucosal surfaces including lips or inside the mouth.
• Do not use SYLKE® Skin Closure near the eye or over eyelids.
• Do not use SYLKE® Skin Closure on intimate areas.
• SYLKE® Skin Closure is made with a long-lasting adhesive and is intended to be worn for two weeks with regular bathing. Early removal of SYLKE® Skin Closure may result in skin stripping, pain, and/or redness. SYLKE® Skin Closure may be soaked in warm soapy water to soften the adhesive and aid in early removal.
• If signs of infection are present around the wound covered by SYLKE® Skin Closure, contact a medical professional.
• SYLKE® Skin Closure should not be used below the skin surface.
• Do not use SYLKE® Skin Closure if the sterile package is damaged or compromised.
• Do not swim or otherwise immerse the wound in water for prolonged periods. Immersing the SYLKE® Skin Closure in water may cause the bandage to lose adhesiveness resulting in early detachment.

Recommended storage conditions: below 30°C (86°F), away from moisture, direct heat, and direct light. Do not use after expiration date.

SYLKE® Skin Closure is sterilized by ethylene oxide gas. Do not resterilize. Do not use if package is opened or damaged. Do not use if SYLKE® Skin Closure strip is damaged or discolored. Discard any unused material.

SYLKE® Skin Closure should only be used on clean, dry wounds when the skin edges of the wound are closely positioned without effort. Examine environment where SYLKE® Skin Closure will be handled and applied and ensure the absence of visible dirt or contaminants. See reverse side for steps of application.

1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion of SYLKE® Skin Closure to the wound edges.
2. Open sterile pouch. Remove SYLKE® Skin Closure strip from pouch.
3. Grasp strip and remove pre-slit 1.5" tab to expose adhesive layer.
4. Position adhesive portion at least 1 cm over the end of the wound and press gently to ensure full adhesion to skin.
5. Remove liner while pressing adhesive strip over length of wound until at least 1 cm of SYLKE® Skin Closure extends over the edge of the wound. If length of the wound exceeds length of SYLKE® Skin Closure, repeat previous steps with additional devices.
6. Trim excess dressing with clean scissors.
7. Press gently along entire strip to secure. Proper adhesion is achieved by applying pressure evenly across the strip.

• Do not swim or fully submerge the wound while wearing SYLKE® Skin Closure. Doing so will affect adhesion qualities.
• Keep wound clean and free of dirt and debris. Dirt trapped in the SYLKE® Skin Closure may cause irritation or infection.
• Contact a medical professional if signs of infection or irritation are present.
• Remove SYLKE® Skin Closure after 14 days.
• SYLKE® Skin Closure is not indicated for re-use of the device. The device should be discarded once removed.

1. Gently lift the edge of SYLKE® Skin Closure at one end of the wound.
2. Slowly peel SYLKE® Skin Closure away from skin along the line of the wound. Use other hand to stabilize the wound to decrease tension as the SYLKE® Skin Closure strip is peeled off.
3. If SYLKE® Skin Closure does not easily remove from skin, soak strip in warm water to soften adhesive.
4. Once fully removed, discard the used wound closure. Do not reuse or resterilize the device.
5. Any residual adhesive and/or dried wound exudate can be gently cleaned from the skin with warm soapy water. If residue remains, an alcohol pad may be used to loosen adhesive remnants.

In the event of a serious incident, such as an adverse reaction or complication, the physician or user should reach out to Sylke, Inc. by emailing quality@sylke.com.

support@sylke.com

Sylke, Inc.
4150 Regents Park Row, Ste 300
La Jolla, CA 92037
United States