NYLON MONOFILAMENT sutures
Golnit NYLON MONOFILAMENT Suture is a non-absorbable, nonabsorbable, monofilament, sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. Nylon Monofilament sutures are dyed black to enhance visibility in tissue. The suture is also available undyed (clear).
- NYLON MONOFILAMENT suture is a nonabsorbable, monofilament, sterile surgical suture
- NYLON MONOFILAMENT suture is available from USP size 10-0 to 2
- Easily passes through the tissue thanks to its low coefficient of friction
DESCRIPTION
NYLON MONOFILAMENT suture is a nonabsorbable, monofilament, sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. NYLON MONOFILAMENT sutures are dyed black or blue to enhance visibility in tissue. The suture is also available undyed (clear).
INDICATIONS
NYLON MONOFILAMENT suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
ACTIONS
NYLON MONOFILAMENT suture elicits a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. NYLON MONOFILAMENT suture is not absorbed, progressive hydrolysis of the nylon in vivo may result in gradual loss over time of tensile strength.
CONTRAINDICATIONS
Due to gradual loss of tensile strength, which may occur over prolonged periods in vivo, nylon suture should not be used where permanent retention of tensile strength is required.
WARNINGS
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing NYLON MONOFILAMENT suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Do not resterilize. Discard opened packages and unused sutures.
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 must be followed for the management of infected or contaminated wounds.
PRECAUTIONS
In handling this 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 holders.
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 circumstances and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.
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.
ADVERSE REACTIONS
Adverse effects associated with the use of this device include wound dehiscence, gradual loss of tensile strength over time, 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 result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.
STORAGE
We recommend that the suture shall be stored under at a temperature of between 5 °C and 40 °C and relative humidity not exceeding 80%; the air shall not contain any aggressive admixtures.
PRODUCT PACKAGING
Golnit nonabsorbable sutures are packaged in two-pouch system of inner pouch and outer pouch. Golnit uses medical grade heat-sealable pouches that are for single use only and conform to the international product standards and norms: ISO 11607-1:2006, ISO 11607-2:2006, EN 868-5:2009.
METHODS OF STERILIZATION
Golnit nonabsorbable sutures are sterilized by validated ethylene oxide (EtO) sterilization system.
