How To Use CutisSeal® Topical B
Please Read Carefully
CutisSeal® Topical B tissue adhesive is Class-IIa medical device for topical use that fulfils the requirements of EU Medical Device Directive 93/42 EEC.
The product is a sterile, ready to use cyanoacrylate adhesive to be used for the closure of easily opposable wounds. It is an amber liquid that, when in contact with skin tissue, quickly polymerises into a thin, elastic waterproof film. It has high tensile strength and adheres firmly to the skin.
The adhesive dries within 60 secs on contact with tissue. When set, the adhesive forms an elastic and waterproof film, that can act as an effective microbial barrier.
How To Use
Open the blister pack and take out one sterile single-dose vial. Before using the product, check the adhesive is fluid and transparent. If the product looks thick and/or turbid, do not use it. In the event of damage to sterile package or seal integrity please dispose of appropriately, resterilisation is not appropriate. Use the product immediately after opening the single-dose vial. Never apply the adhesive into a wound, but only on to the skin after opposing the edges of the wound, which will have been preliminarily cleaned and dried. Keep the edges of the wound close together until the adhesive has dried, approximately 1 minute. Once polymerised, the adhesive acts as an effective microbial barrier against the most common infectious bacteria.
Please refer to the images below for full instruction:
Step 1 ▶
Ensure the vial is in the vertical position, with the cap turned up.
Step 2 ▶
Let the adhesive flow down from the neck of the vial to ensure no accidental leakage.
Step 3 ▶
Remove break tab seal by twisting and pulling simultaneously.
Step 4 ▶
Screw the dispenser tip onto the neck of the vial and make sure it is securely fastened before applying the adhesive.
Exercise care while doing this operation as excessive pressure on the body of the vial will cause leakage of the adhesive through the dispenser tip.
Step 5 ▶
Overturn the vial and gently press the body of the vial so as to let a tiny amount of adhesive flow out onto the padded dispenser tip.
Step 6 ▶
Apply a thin film of adhesive onto the wound without pressing too hard on the body of the vial.
Application of an excessive amount of product would result in a longer polymerisation time which would reduce the tensile strength of the adhesive at the site of application and would prevent the correct healing of the wound.
Contraindications
Never apply the adhesive inside the edges of the wound but only on the skin after opposing the edges of the wound, which will have been preliminarily cleaned and dried. Do not apply on infected or chronic wounds. Do not use on or near mucosal surfaces and junctions. Do not use on patients with a known hypersensitivity to cyanoacrylate and formaldehyde.
Precautions
Always apply a tiny amount of adhesive. When applied, it takes approx. 30sec – 1min for the solution to polymerise following the application on the wound. A second film of adhesive may be applied over the first one only after the first layer has polymerised. Any excess product can be removed with a dry, sterile, non-stick wound pad within 5-6 seconds of its application. Avoid contact with the eyes. If applying in the vicinity of the eye, position the patient so that any run-off is away from the patient’s eye. Gauze should be placed over the eye. Petroleum jelly may be placed around the eye to act as a preventative barrier. Avoid placing petroleum jelly in areas where bonding is desired. If the adhesive gets into the eye, immediately rinse the area with copious amounts of water or saline. If the eye is bonded closed, cover the eye with gauze soaked in warm water. Keep the eye covered until all the adhesive has debonded. Do not force the eye open. If there is concern about residual adhesive in the eye, contact an ophthalmologist.. If the adhesive comes into contact with surgical instruments, remove with acetone.
Warning
Only physicians experienced in the use of the product must use the adhesive. The user is responsible for the proper use of the product. Do not use the adhesive if thick and/or turbid. The adhesive is disposable product. Do not reuse the device after the first opening. The reusing involves substantial risk of infection to the patient for lack of content sterility, fault of adhesive properties and of product efficacy by its contact with air. Any unused adhesive must be disposed of. After application, some minor, local inflammatory reaction may very rarely occur. The exothermic reaction that occurs during the polymerisation process, although always below 50°C, could sometimes cause a slight burning sensation in hypersensitive patients (such as children or elderly people) on the site of application. Application may be used in conjunction with but not in place of, deep dermal stitches
Storage & Expiry
- CutisSeal® Topical B can be stored at room temperature for a period of up to 23 months from the date of manufacture. DO NOT USE the product after the expiry date.
Sterility
- The product is sterile.
Pack
- One pack – C-NBCA 0.60 – contains 10 x 0.60ml single-dose vials