Enhanced TDS
Identification & Functionality
- Chemical Family
- Product Type
- Technologies
Features & Benefits
- Ready-to-Use Product Features
- Product Highlights
The Surgiseal® adhesive formula is the only topical skin adhesive in the world to receive FDA 510k Clearance in demonstrating inhibition of gram positive and gram negative bacteria growth.
- High-strength 2-octyl cyanoacrylate formulation: Surgiseal is made with a 2-octyl cyanoacrylate formulation, featuring superior tensile strength, which helps produce better clinical outcomes.
- Octylflex® technology: No formula on the market measures higher in flexibility than the proprietary Surgiseal formula. Flexibility contributes to patient comfort and preserves the integrity of the adhesive, preventing premature sloughing.
- Microbial barrier and water-resistant protection: Patients are protected after application: Surgiseal adhesive forms a barrier on the skin, preventing bacteria and water from reaching the wound, reducing the chance of infection and allowing the patients to shower immediately.
- Optimum viscosity: Years of research and development have resulted in a formula that neither runs nor clogs, resulting in the right balance of effectiveness and efficiency every time.
Applications & Uses
- Markets
- Applications
- Direction for Use
Indications:
Surgiseal® is intended for topical applications 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. Surgiseal may be used in conjunction with, but not in place of, deep dermal sutures.
1. Fold over the Surgiseal adhesive applicator at the sponge. You will hear a snap.
2. Hold with the sponge facing downward. No squeezing is necessary in normal application. If you require greater flow, you may very gently squeeze.
3. Approximate the wound edges together & apply in one thick layer or two thin layers. If two thin layers applied, allow 30 seconds dry time in between layers.
Direction for Use:
- Before the use of Surgiseal the wound must be thoroughly cleaned.
- Use normal surgical protocol for wound preparation before treatment of Surgiseal topical skin adhesive and be certain to suture deep subcutaneous layers.
- Dry the injured area with sterile gauze, removing all moisture for proper tissue bonding of Surgiseal to the skin.
- To prevent inadvertent flow of Surgiseal topical skin adhesive to unintended areas of the body, the wound should be held in a horizontal position and the Surgiseal topical skin adhesive should be applied from above the wound.
- Remove the applicator from the blister pouch. Hold the applicator with the thumb and forefinger away from patient to prevent any unintentional placement of the liquid Surgiseal topical skin adhesive into the wound or on the patient.
- While holding the applicator, and with the applicator sponge facing upward, snap at tip along the perforated line and fold over.
- Gently squeeze the liquid Surgiseal adhesive from the applicator bubble while saturating the sponge.
- Approximate the wound edges together using either gloved fingers or sterile forceps.
- Slowly apply the liquid Surgiseal topical skin adhesive in one thick, continuous layer or two thin layers. If two thin layers are applied, allow 30 seconds dry time in between layers.
- Maintain manual approximation of the opposed wound edges together for approximately 60 seconds once the final coat of Surgiseal is applied.
- Note: Excessive pressure of the applicator tip against the wound edges or surrounding skin can result in forcing the wound edges apart and allowing Surgiseal topical skin adhesive into the wound. Surgiseal topical skin 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 1.0 minute after the final layer is applied. Full polymerization is expected when the top Surgiseal topical skin adhesive layer is no longer tacky.
- Protective dry dressings, such as gauze, may be applied only after Surgiseal topical skin adhesive film is completely solid/polymerized and 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.
- Patients should be instructed to not pick at the polymerized film of Surgiseal topical skin adhesive. Picking at the film can disrupt its adhesion to the skin and cause dehiscence of the wound. Picking at the film can be diskouraged by an overlying dressing.
- Apply a dry protective dressing for children or other patients who may not be able to follow instructions for proper wound care.
- Patients should be instructed that until the polymerized film of Surgiseal topical skin 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.
- If removal of Surgiseal topical skin adhesive is necessary for any reason, carefully apply petroleum jelly or acetone to the Surgiseal topical skin adhesive film to help loosen the bond. Peel off the film, do not pull the skin apart.
- Once the surface is tack- free, full polymerization has generally occurred.
Properties
- Physical Form
Regulatory & Compliance
- Certifications & Compliance
Technical Details & Test Data
- Antibacterial Actions
- SurgiSeal has been shown with in vitro studies to provide a strong holding strength of approximated wound skin edges.
- Studies have shown in vitro that SurgiSeal has bactericidal activity against gram- and gram+ bacteria; Escherichia coli, Methicillin-resistant Staphylococcus aureus, P aeruginosa, Klebsiella pheumoniae, Staphylococcus epidermidis, Corynebacterium pseudodiptheriticum, Staphylococcus aureus, known to contribute to surgical site infections.
- These evaluations have shown that a 7 log or greater bacterial challenge of these microorganisms do not survive on contact when incorporated within the adhesive on application. However, the clinical relevance of this activity has not been demonstrated.
Safety & Health
- Precautions
- Do not use on any wounds with evidence of microbial, bacterial or fungal infections or gangrene.
- Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids or with dense natural hair.
- Do not use on patients that have a hypersensitivity to cyanoacrylates or formaldehyde.
- Adverse Reactions
- Adverse reactions may occur if adhesive makes contact with the eye.
- Adverse reactions may occur to patients that have a hypersensitivity to cyanoacrylates or formaldehyde.
- Surgiseal topical skin adhesive should always be applied in one thick, continuous layer or two thin layers so that large amounts of liquid are not allowed to collect, resulting in thermal diskomfort for the patient.
Packaging & Availability
- Packaging Type
- Regional Availability
- Availability
Surgiseal is a sterile, easy to use, single-dose applicator, packaged in a thermal formed blister pouch. The applicators are packaged in a box that fits precisely on the skin shelf. The applicator has a perforation in the middle allowing for ease of application. The applicator contains a topical skin adhesive.
Storage & Handling
- Storage Condition
Recommended storage conditions are at or below 30ºC, 86ºF, away from moisture, direct heat and direct light. Do not use after expiration date.