Trofilen is a synthetic, non-absorbable, sterile surgical monofilament suture. It is made of a biologically inert polymer Polyvinylidene fluoride (PVDF).
Trofilen is dyed blue for higher visibility.
Trofilen meets all requirements for non-absorbable surgical sutures specified by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).
Trofilen is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, plastic, neurological and ophthalmic surgery procedures.
Sutures are for single use only.
Trofilen elicits a minimal acute inflammatory reaction in tissue, which is followed by a gradual encapsulation of the suture by fibrous connective tissue. Trofilen is not absorbed, nor is it subject to degradation or weakening by the action of tissue enzymes. The lack of adherence to tissues has facilitated the use of Trofilen as a pull-out suture.
Trofilen is supplied in USP sizes 7/0 to 2 (EP 0.5 - 5) in boxes of 12 pouches.
The product should be kept dry and clean. Keep away from direct sunlight. Do not use products after expiry (“use by”) date.
Users should be familiar with surgical procedures and techniques involving non-absorbable sutures before employing Trofilen for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Sterility is preserved only when opened under sterile conditions.
Do not re-sterilize.
This device is single use. Known hazards with reuse or re-sterilization of opened/original packages of the device are cross contamination, infection and trauma.
Discard opened packages and unused sutures.
Do not use opened or damaged products.
As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the
urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds.
In handling this or any other suture material, care should be taken to avoid damage from handling.
Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle
As with any suture material, adequate knot security requires the accepted surgical technique of flat and
square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
When lasering and electro-cautering is used, avoid damaging the sutures. Users should avoid electrocautering and/or laser on suture.
To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half
(1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.
Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.
Discard used needles in " sharps" containers.
Do not use expired products.
Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may cause complications in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of blood borne pathogens.