Sylke® Adhesive Wound Closure Instructions For Use (OTC)

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 32 cm by 2.5 cm strip, allowing use on a variety of wound lengths and for any excess to be trimmed away.

Intended Use:

Sylke® Adhesive Wound Closure is indicated for use as a topical wound closure device in the treatment and coverage of simple lacerations, cuts, puncture wounds, and post-surgical wounds. Sylke® Adhesive Wound Closure may be used in conjunction with skin sutures to assist in the closure of skin edges. Sylke® Adhesive Wound Closure is designed for wear for two weeks with regular bathing.

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 to the underlying skin. Sylke® Adhesive Wound Closure may be soaked in warm salt water or dabbed with a rubbing alcohol-soaked cotton ball to soften the adhesive and aid in early removal.
  • If signs of infection are present around the wound covered by Sylke® Adhesive Wound Closure, remove the wound closure and 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 will cause the bandage to lose adhesion.

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. To apply Sylke® Adhesive Wound Closure:

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

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

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3. Grasp strip and remove pre-slit 1” tab to expose adhesive layer.

aligning strip on wound visual.webp__PID:ffdfb485-8d62-4ba8-8759-7ff21799fdfa

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

placing strip on patient wound visuall.webp__PID:dfb4858d-627b-4887-997f-f21799fdfa86

5. Remove liner while guiding and gently pressing adhesive strip over the length of the wound until at least 1 cm of Sylke® 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.

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6. Trim excess dressing with clean scissors.

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7. Press gently to secure.

Instructions for Wear:

- Do not swim or fully submerge the wound while wearing Sylke® Adhesive Wound Closure. Doing so will affect adhesion qualities of the Wound Closure.
- 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 the Sylke® Adhesive Wound Closure after 14 days.

Removal Instructions:

  • Gently lift the edge of Sylke® Adhesive Wound Closure at one end of the wound.
  • 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.
  • If Sylke® Adhesive Wound Closure does not easily remove from skin, dab the strip edges with rubbing alcohol from a cotton ball or alcohol wipe.
  • Once fully removed, discard the used wound closure. Do not reuse or resterilize the device.
  • 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.

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.

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