high viscosity tissue adhesive
derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2 which allows the user to easily see where the adhesive has been applied.
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple thoroughly cleansed trauma-induced lacerations.
As applied to skin, derma+flex® QS™ is syrup-like in viscosity and polymerizes quickly. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to the migration of the liquid adhesive from the wound site.
derma+flex™ QS™ is provided in a single use aluminum collapsible tube packaged in a sterile Tyvek®* pouch also containing 2 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows the spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive.
*Tyvek is a registered trademark of E.I. du Pont de Nemours and Company Corporation.
FREQUENTLY ASKED QUESTIONS
Q: Has derma+flex® QS™ been cleared by the FDA?
A: Yes, derma+flex® QS™ has been cleared by the FDA as a Class II medical device.
Q: What are the advantages of derma+flex® QS™ over what I currently use?
A: Current butyl monomer products are brittle.1 These products tend to easily crack and slough off especially in areas that require skin movement and flexibility.1 Butyl products have been around since the mid 1970’s.The current market leading 2-Octyl monomer product requires an external initiator to make the adhesive polymerize (dry).1These initiators cause a reaction resulting in increased heat to the wound site.1 This makes application of the adhesive on patients with trauma injuries more uncomfortable.2 derma+flex® QS™ is not brittle but is flexible and does not use an external initiator. As a result, it does not burn and can be used in most areas of the body with the exception of high tension areas that require sutures, staples, or adhesive strips. derma+flex® QS™ is meant for external dermal application only and should not contact the eyes. derma+flex® QS™ can be used in conjunction with the noted closure devices in high tension areas to provide added closure and protection against water, thus allowing the patient to shower.2
Q: What is the shelf life of derma+flex® QS™?
A: Currently the shelf life is 6 months from the date of manufacture but additional studies are ongoing to increase the shelf life.1
Q: How many times can you use a derma+flex® QS™ tube?
A: Each tube is intended for single patient use. The product will not polymerize in the dauber and harden like most products do, allowing derma+flex® QS™ to be used over multiple incisions on the same patient during the same procedure if necessary. Any remaining adhesive left inside the delivery device once the procedure is over should be appropriately discarded.