SILK sutures
Golnit SILK Suture is a nonabsorbable, braided, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk sutures are processed to remove the natural waxes and gums. Silk suture is dyed black and coated with silicone. Silk suture is also available in its natural color coated with silicone.
- SILK suture is a nonabsorbable, braided, sterile, surgical suture
- SILK suture is available from USP size 11-0 to 5
- SILK suture are composed of an organic protein called fibroin
- Easily passes through the tissue and forms reliable knots
DESCRIPTION
Silk suture is a nonabsorbable, braided, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk sutures are processed to remove the natural waxes and gums. Silk suture is dyed black and coated with silicone. Silk suture is also available in its natural color.
INDICATIONS
Silk suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
ACTIONS
Silk suture elicits an acute inflammatory reaction in tissue, which is followed by a gradual encapsulation of the suture by fibrous connective tissue. While silk sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in vivo may result in gradual loss of all of the suture’s tensile strength over time.
CONTRAINDICATIONS
The use of this suture is contraindicated in patients with known sensitivities or allergies to silk. Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo. Silk 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 silk suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
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.
Do not resterilize. Discard opened packages and unused sutures.
PRECAUTIONS
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 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 circumstance and the experience of the surgeon.
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 all tensile strength over time, allergic response in patients that are known to be sensitive to silk, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, 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.
