DEVICE DESCRIPTION: 

SYLKE® Skin Closure is a single-use, sterile, woven silk fibroin mesh strip coated on one side with a pressure-sensitive adhesive. The adhesive surface is covered by a removable release liner with a pre-slit tab. 

HOW SUPPLIED: 

Each SYLKE® Skin Closure strip is provided sterile in an individually sealed pouch. The device is available in multiple lengths and widths. Refer to product label and regional catalog for specific dimensions and available packaging configurations.

INTENDED USE:  

SYLKE® Skin Closure is a sterile, single-use, silk fibroin mesh strip with a pressure-sensitive adhesive intended for topical skin closure and wound support. The device is used to hold together well-approximated skin edges of a wound, and to cover and protect the wound. The device is designed for wear of up to 14 days. SYLKE® Skin Closure may be applied by healthcare professionals or, where permitted by applicable laws and regulations, by lay users following the included instructions.  

INDICATIONS:  

SYLKE® Skin Closure is indicated for topical closure and coverage of thoroughly cleansed simple lacerations and minor cuts, where it may be used as the primary skin closure. SYLKE® Skin Closure is also indicated for topical closure and coverage of post-surgical skin incisions in which deeper layers have been closed, where it is used as an adjunct to sutures or staples. Wound edges must be easily approximated without tension. 

CONTRAINDICATIONS: 

WARNINGS: 

 PRECAUTIONS: 

SYLKE® Skin Closure is not made with natural rubber latex. 

SYLKE® Skin Closure has not been evaluated for use in hyperbaric oxygen therapy (HBOT) environments. Safety and performance under hyperbaric conditions have not been established. Healthcare providers should use clinical judgment when considering the use of SYLKE® Skin Closure on patients undergoing HBOT.  

STORAGE: 

For best results, store in a cool, dry place away from direct sunlight. Do not use after the expiration date printed on the label. 

STERILITY: 

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

APPLICATION: 

SYLKE® Skin Closure should only be used on clean, dry wounds when the skin edges of the wound are easily approximated without tension. Examine environment where SYLKE® Skin Closure will be handled and applied and ensure the absence of visible dirt or contaminants. 

1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion of SYLKE® Skin Closure to the wound edges. (FIGURE A)
2. Open sterile pouch. Remove SYLKE® Skin Closure strip from pouch. (FIGURE B)
3. With the release liner still in place, hold the strip alongside the wound to measure the required length. The strip should extend at least 1 cm beyond each end of the wound. (FIGURE C)
4. Using clean scissors, trim the strip to the appropriate length. (FIGURE D)
5. Hold the strip and peel back the pre-slit tab to expose the adhesive. (FIGURE E)
6. Place the exposed adhesive section on the skin at least 1 cm beyond one end of the wound. Press firmly to anchor the strip to the skin. (FIGURE F)
7. While holding the anchored end in place, slowly peel away the release liner and press the adhesive strip along the length of the wound. The strip should extend at least 1 cm beyond the opposite end of the wound. If the wound length exceeds the length of a single strip, repeat previous steps with additional devices. (FIGURE G)
8. Press firmly along the entire length of the strip to secure. Check that all edges are flat against the skin and no sections are lifted. Proper adhesion is achieved by applying pressure evenly across the strip. (FIGURE H)

INSTRUCTIONS FOR WEAR: 

REMOVAL INSTRUCTIONS: 

1. Gently lift the edge of SYLKE® Skin Closure at one end of the wound.
2. Slowly peel SYLKE® Skin Closure away from the skin along the line of the wound. Use other hand to stabilize the surrounding skin 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 skin closure strip in a standard disposal bin. Do not re-use or re-sterilize 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, a medical adhesive remover may be used to loosen adhesive remnants.