Derma+Flex® is a sterile high viscosity topical skin adhesive, formulated to facilitate easy application. It is provided in a 0.7 g single use aluminium collapsible tube and applicator packaged in a rigid PETG blister with a Tyvek® lid. The applicator is comprised of a self-puncturing cap and a soft, angled tip. When applied to the skin, Derma+Flex® gel adhesive sets quickly without burning or stinging the patient. The syrup-like viscosity makes the adhesive easy to apply and helps prevent it running from or into the wound. Derma+Flex® topical skin adhesive forms a flexible, waterproof microbial barrier over easily approximated wound edges to facilitate wound healing. The tube can be used for one or several indicated wounds on the same patient.
Derma+Flex® topical skin adhesive is for use by medical professionals to close surgical incisions and minor traumatic wounds with easily opposable skin edges in areas of low skin tension. It may be used in conjunction with, but not in place of, deep dermal sutures. In vitro studies have shown Derma+Flex® acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
- Derma+Flex® topical skin adhesive should not be used internally, on or near the mucosa, on wounds of a decubitus etiology, on animal or human bites, or on infected wounds.
- Care should be taken to avoid contact with the eyes.
- Derma+Flex® topical skin adhesive should not be placed into incisions or lacerations and should not be used as a primary wound closure method in areas of high skin tension or in areas prone to movement,
such as over joints.
- Derma+Flex® may be used in areas of dense natural hair as long as such areas are properly prepared and care is taken to prevent trapping hair in the wound.
- Derma+Flex® should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.
- It should not be used on patients with known allergies to cyanoacrylate or formaldehyde, or on patients with preoperative systemic infections, uncontrolled diabetes, or other diseases or conditions known to interfere with wound healing.
- Localised sensitization may occur.
- Excessive pressure of the applicator tip against wound edges or surrounding skin can force the wound edges apart and allow adhesive into the wound. Adhesive within the wound could delay wound healing and/or result in adverse cosmetic outcome.
- Do not place Derma+Flex® topical skin adhesive in a procedure pack/tray that is to be sterilized prior to use. Exposure of Derma+Flex® topical skin adhesive, after its final manufacture, to excessive heat (as in autoclaves) or radiation (such as gamma or electron beam), is known to increase its viscosity and may render the product unstable.
- Potential systemic toxicity of this product is unknown.
- The product is for single patient use only. Multiple use of the device on different patients increases the possibility of transfer of infection agents.