SYLKE® Adhesive Wound Closure

DEVICE DESCRIPTION:
SYLKE® Adhesive Wound Closure is a single use, sterile, woven silk mesh coated with a long lasting, pressure sensitive adhesive.

HOW SUPPLIED:
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.

INTENDED USE:
SYLKE® Adhesive Wound 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.

INDICATIONS:
SYLKE® Adhesive Wound 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.

CONTRAINDICATIONS:
• SYLKE® Adhesive Wound 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® Adhesive Wound 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® Adhesive Wound Closure is contraindicated for use in high-tension wounds without the support of additional skin closure devices i.e. sutures.

• SYLKE® Adhesive Wound Closure is contraindicated for use on wounds that are actively bleeding.

WARNINGS:
• Do not use SYLKE® Adhesive Wound 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® Adhesive Wound Closure on mucosal surfaces including lips or inside the mouth.

• Do not use SYLKE® Adhesive Wound Closure near the eye or over eyelids.

• Do not use SYLKE® Adhesive Wound Closure on intimate areas.

• SYLKE® Adhesive Wound Closure is made with a long-lasting adhesive and is intended to be worn for two weeks with regular bathing.

• Early removal of SYLKE® Adhesive Wound Closure may result in skin stripping, pain, and/or redness. SYLKE® Adhesive Wound 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® Adhesive Wound Closure, contact a medical professional.

• SYLKE® Adhesive Wound Closure should not be used below the skin surface.

• Do not use SYLKE® Adhesive Wound 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® Adhesive Wound Closure in water may cause the bandage to lose adhesiveness resulting in early detachment.

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

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

APPLICATION:
SYLKE® Adhesive Wound 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® Adhesive Wound Closure will be handled and applied and ensure the absence of visible dirt or contaminants. See reverse side for steps of application.

Step 1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion SYLKE® Adhesive Wound Closure to the wound edges.

Step 2. Open sterile pouch. Remove SYLKE® Adhesive Wound Closure strip from pouch.

Step 3. Grasp strip and remove pre-slit 1.5 tab" to expose adhesive layer.

Step 4. Position adhesive portion at least 1 cm over the end of the wound and press gently to ensure full adhesion to skin.

Step 5. Remove liner while pressing adhesive strip over length of wound until at least 1 cm of SYLKE® Adhesive Wound Closure extends over the edge of the wound. If length of the wound exceeds length of SYLKE® Adhesive Wound Closure, repeat previous steps with additional devices.

Step 6. Trim excess dressing with clean scissors.

Step 7. Press gently along entire strip to secure. Proper adhesion is achieved by applying pressure evenly across the strip.

INSTRUCTIONS FOR WEAR:
• Do not swim or fully submerge the wound while wearing SYLKE® Adhesive Wound Closure. Doing so will affect adhesion qualities.

• Keep wound clean and free of dirt and debris. Dirt trapped in the SYLKE® Adhesive Wound Closure may cause irritation or infection.

• Contact a medical professional if signs of infection or irritation are present.

• Remove SYLKE® Adhesive Wound Closure after 14 days.

• SYLKE® Adhesive Wound Closure is not indicated for re-use of the device. The device should be discarded once removed.

REMOVAL INSTRUCTIONS:
Step 1. Gently lift the edge of SYLKE® Adhesive Wound Closure at one end of the wound.

Step 2. Slowly peel SYLKE® Adhesive Wound Closure away from skin along the line of the wound. Use other hand to stabilize the wound to decrease tension as the SYLKE® Adhesive Wound Closure strip is peeled off.

Step 3. If SYLKE® Adhesive Wound Closure does not easily remove from skin, soak strip in warm water to soften adhesive.

Step 4. Once fully removed, discard the used wound closure. Do not reuse or resterilize the device.

Step 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.

INFORM THE MANUFACTURER
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.

MANUFACTURER INFORMATION
Sylke, Inc.
4150 Regents Park Row, Ste 300
La Jolla, CA 92037