indications for use Indications for Use

derma+flex® QS™
High Viscosity Tissue Adhesive (2-Octyl Cyanoacrylate)

DESCRIPTION

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. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows 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. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes.
derma+flex® QS™ High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In vitro studies have shown that derma+flex® QS™ high viscosity tissue adhesive 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.

INDICATIONS
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only 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. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

CONTRAINDICATIONS
• Do not use on any wound with evidence of active infection, gangrene, or wounds of decubitus etiology.
• Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips), or on skin which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp).
• Do not use on patients with a known hypersensitivity to cyanoacrylate or formaldehyde.

WARNINGS
derma+flex® QS™ High Viscosity Tissue Adhesive is a fast setting adhesive capable of adhering to most body tissue and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, and any surfaces or equipment that are not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided.
• Polymerization of derma+flex® QS™ High Viscosity Tissue Adhesive may be accelerated by water or fluids containing alcohol: derma+flex® QS™ High Viscosity Tissue Adhesive should not be applied to wet wounds.
derma+flex® QS™ High Viscosity Tissue Adhesive should not be applied to the eye. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.
• When closing facial wounds near the eye with derma+flex® QS™ High Viscosity Tissue Adhesive, position the patient so that any run-off of adhesive is away from the eye. The eye should be closed and protected with gauze. Prophylactic placement of petroleum jelly around the eye, to act as a mechanical barrier or dam, can be effective in preventing inadvertent flow of adhesive into the eye. derma+flex® QS™ High Viscosity Tissue Adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where derma+flex® QS™ High Viscosity Tissue Adhesive is intended to adhere.
derma+flex® QS™ High Viscosity Tissue Adhesive should not be used below the skin because the polymerized material is not absorbed by tissue and can elicit a foreign body reaction.
derma+flex® QS™ High Viscosity Tissue Adhesive should not be used in high skin tension areas or across areas of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application of another wound closure device (e.g., sutures, skin staples, or adhesive wound closure strips) prior to application of derma+flex® QS™ High Viscosity Tissue Adhesive.
derma+flex® QS™ High Viscosity Tissue Adhesive treated wounds should be monitored for signs of infection. Wounds with signs of infection, such as erythema, edema, warmth, pain and pus, should be evaluated and treated according to standard practice for infection.
derma+flex® QS™ High Viscosity Tissue Adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.
derma+flex® QS™ High Viscosity Tissue Adhesive should only be used after wounds have been cleaned, debrided and are otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to assure adequate cleansing and debridement.
• 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. Therefore, derma+flex® QS™ High Viscosity Tissue Adhesive should be applied with a very light brushing motion of the applicator tip over easily approximated wound edges.
derma+flex® QS™ High Viscosity Tissue Adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper application technique of derma+flex® QS™ High Viscosity Tissue Adhesive any potential sensation of heat or pain experienced by the patient is minimized.

derma+flex® QS™ High Viscosity Tissue Adhesive is packaged for single patient use. Discard remaining opened material after each  wound closure procedure.
• Do not resterilize derma+flex® QS™ High Viscosity Tissue Adhesive.
• Do not place derma+flex® QS™ High Viscosity Tissue Adhesive in a procedure pack/tray that is to be sterilized prior to use. Exposure of derma+flex® QS™ High Viscosity Tissue 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 unusable.
• Potential systemic toxicity of this product is unknown

PRECAUTIONS
• Do not apply liquid or ointment medications or other substances to the wound after closure with derma+flex® QS™ High Viscosity Tissue Adhesive, as these substances can weaken the polymerized film and allow for wound dehiscence. derma+flex® QS™ High Viscosity Tissue Adhesive permeability by topical medications has not been studied.
derma+flex® QS™ High Viscosity Tissue Adhesive permeability by fluids is not known and has not been studied.
derma+flex® QS™ High Viscosity Tissue Adhesive, as a liquid, is syrup-like in viscosity. To prevent inadvertent flow of liquid derma+flex® QS™ High Viscosity Tissue Adhesive to unintended areas the patient should be positioned so that inadvertent flow would be away from unwanted areas.
• Hold applicator upward and away from yourself and the patient and squeeze the contents of the tube from the bottom of the tube towards the applicator.
derma+flex® QS™ High Viscosity Tissue Adhesive should be used within 30 minutes after attaching the self-puncture applicator on the tube to avoid premature polymerization. The adhesive may be used as long as it remains in liquid form and has not been allowed to become contaminated.
• If unintended bonding of intact skin occurs, peel, but do not pull the skin apart. Petroleum jelly or acetone may help loosen the bond. Other agents such as water, saline, Betadine® Antibiotics, HIBICLENS† (chlorhexidene gluconate), or soap, are not expected to immediately loosen the bond.
• Safety and effectiveness of derma+flex® QS™ High Viscosity Tissue Adhesive on wounds of patients with peripheral vascular disease, insulin dependent diabetes mellitus, blood clotting disorders, personal or family history of keloid formation or hypertrophy, or burst stellate lacerations, have not been studied.
• Safety and effectiveness of derma+flex® QS™ High Viscosity Tissue Adhesive on the following wounds has not been studied: animal or human bites; puncture or stab wounds.
• Safety and effectiveness on wounds that have been treated with derma+flex® QS™ High Viscosity Tissue Adhesive and then exposed for prolonged periods to direct sunlight or tanning lamps have not been studied.
• Safety and effectiveness of derma+flex® QS™ High Viscosity Tissue Adhesive on wounds in vermilion surfaces has not been studied.

ADVERSE REACTIONS
• Reactions may occur in patients who are hypersensitive to cyanoacrylate or formaldehyde. See CONTRAINDICATIONS.
• Adverse reactions may be experienced following derma+flex® QS™ High Viscosity Tissue Adhesive contact with the eye.

DIRECTIONS FOR USE

Step One – Cleanse and Prepare the Wound

A. The application of derma+flex® QS™ High Viscosity Tissue Adhesive requires thorough wound cleansing. Follow standard surgical practice for wound preparation before application of high viscosity derma+flex® QS™ High Viscosity Tissue Adhesive (i.e., anesthetize, irrigate, debride, obtain hemostasis and close deep layers).

B. Pat the wound dry with sterile gauze (dry) to assure direct tissue contact for adherence of the derma+flex® QS™ High Viscosity Tissue Adhesive to the skin. Moisture and blood accelerates derma+flex® QS™ High Viscosity Tissue Adhesive’s polymerization and may affect wound closure results.

C. To prevent inadvertent flow of liquid to unintended areas of the body, the wound should be positioned to prevent adhesive from flowing onto the unwanted area. (Figure 1)

Step Two – Opening the Device

derma+flex® QS™ High Viscosity Tissue Adhesive should be used shortly after connecting the applicator tip to the tube holding the adhesive to prevent premature polymerization. Remove the applicator tip from the pouch. Both applicator tips are connected to the tube the same way. To connect the applicator to the tube, hold the applicator tube with the thumb and a finger by the crimped base. While holding the applicator tip, twist the tube in a counter-clockwise motion until the aluminum seal has been pierced. (Figure 2)

 

Step Three – Device Preparation

Apply the tip away from the patient to prevent any unintentional placement of the liquid derma+flex® QS™ High Viscosity Tissue Adhesive into the wound or on the patient. While holding the applicator tube, and with applicator tip pointed upward, invert and gently squeeze the applicator tube just sufficiently to express the liquid derma+flex® QS™ High Viscosity Tissue Adhesive to moisten the applicator tip. When using the nozzle applicator tip, gently squeeze the applicator tube until the adhesive can be seen at the tip, which will allow a more controlled application. Excess adhesive on the tip can be removed with sterile gauze.(Figure 3)

 

Step Four – Application

Approximate wound edges with gloved fingers or sterile forceps. When using the dauber applicator tip, slowly apply the liquid derma+flex® QS™ High Viscosity Tissue Adhesive in one single thin layer that is equal and sufficient to cover the approximated wound edges using a gentle brushing motion. (Figure 4)

The nozzle applicator should be used for focal areas only, avoiding the application of large droplets. Maintain manual approximation of the wound edges for approximately 60 seconds; it may take several minutes for the entire adhesive layer to dry completely.

Additional Information:

NOTE: derma+flex® QS™ High Viscosity Tissue Adhesive polymerizes through an exothermic reaction. If the liquid derma+flex® QS™ High Viscosity Tissue Adhesive is applied so that large droplets are allowed to remain without being evenly spread, the patient may experience a sensation of heat or discomfort. The sensation may be higher on sensitive tissues. NOTE: Excessive pressure of the applicator tip against the wound edges or surrounding skin can result in forcing the wound edges apart and allowing derma+flex® QS™ High Viscosity Tissue Adhesive into the wound. derma+flex® QS™ High Viscosity Tissue Adhesive within the wound could delay wound healing and/or result in adverse cosmetic outcome.
NOTE: Full apposition strength is expected to be achieved about 2.5 minutes after the layer is applied, although the top adhesive layer may remain tacky for up to approximately 5 minutes. Full polymerization is expected when the top derma+flex® QS™ High Viscosity Tissue Adhesive layer is no longer sticky.
NOTE: Do not apply liquid or ointment medications onto wounds closed with derma+flex® QS™ High Viscosity Tissue Adhesive because these substances can weaken the polymerized film, leading to wound dehiscence.
NOTE: Protective dry dressings such as gauze may be applied only after derma+flex® QS™ High Viscosity Tissue Adhesive film is completely solid/polymerized: not tacky to the touch (approximately five minutes after application). Allow the top layer to fully polymerize before applying a bandage.
If a dressing, bandage, adhesive backing or tape is applied before complete polymerization, the dressing can adhere to the film. The film can be disrupted from the skin when the dressing is removed, and wound dehiscence can occur.
NOTE: Patients should be instructed to not pick at the polymerized film of derma+flex® QS™ High Viscosity Tissue Adhesive. Picking at the film can disrupt its adhesion to the skin and cause dehiscence of the wound. Picking at the film can be discouraged by an overlying dressing.

NOTE: Apply a dry protective dressing for children or other patients who may not be able to follow instructions for proper wound care.
NOTE: Patients should be instructed that until the polymerized film of derma+flex® QS™ High Viscosity Tissue Adhesive has sloughed naturally (usually in 5-10 days), there should be only transient wetting of the treatment site. Patients may shower and bathe the site gently. The site should not be scrubbed, soaked, or exposed to prolonged wetness until after the film has sloughed naturally and the wound has healed closed. Patients should be instructed not to go swimming during this period.
NOTE: If removal of derma+flex® QS™ High Viscosity Tissue Adhesive is necessary for any reason, carefully apply petroleum jelly or acetone to the derma+flex® QS™ High Viscosity film to help loosen the bond. Peel off the film, do not pull the skin apart.

HOW SUPPLIED
derma+flex® QS™ High Viscosity Tissue Adhesive is supplied sterile, in a pre-filled, single-use applicator tube and 2 different types of applicator tips, a nozzle tip for precision applications and a dauber tip for general wound closure. The applicator tube contains the liquid adhesive. The applicator tube and the 2 applicator tips are packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch to maintain the device sterile until opened or damaged.
derma+flex® QS™ High Viscosity Tissue Adhesive may be available in boxes of 6 applicators.

STORAGE
Recommended storage conditions: below 30°C, 86°F, away from direct heat. Do not use after expiry date.

STERILITY
derma+flex® QS™ High Viscosity Tissue Adhesive is originally sterilized by dry heat and ethylene oxide gas. Do not resterilize. Do not use if package is opened or damaged. Discard any unused material following completion of medical procedure.

STERILE SINGLE USE ONLY

REPORTING
Healthcare Professional should use the following number 678-879-5446, when reporting adverse reactions or potentially threatening complications involving derma+flex® QS™ High Viscosity Tissue Adhesive.

CAUTION
This product is meant for external dermal application only and should not contact the eyes.
This product should not be ingested, applied internally, or injected intravascularly.

Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.

Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.
Betadine® Trademark of Purdue Fredericks †Registered Trademark of Zeneca Pharmaceuticals

* Tyvek is a registered trademarks of E. I. du Pont de Nemours and Company Corporation

 

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latest news

11-04-2010Microbial Barrier Approval

derma+flex® QS™ has been approved as an effective microbial barrier in independent lab testing.

 
09-21-2010New Physician Endorsements
The Latest Endorsements from the medical community.Read More

08-7-2010derma+flex® QS™ After Care Instructions Posted
derma+flex® QS™ High Viscosity Tissue Adhesive's instructions are now posted in english and spanishRead More
 

 

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