POLIGLECAPRONE 25 suture
POLIGLECAPRONE 25 suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. The sutures are available dyed (violet) and undyed.
POLIGLECAPRONE 25 suture is a monofilament which elicits a minimal acute inflammatory reaction in tissues and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of POLIGLECAPRONE 25 sutures occurs by means of hydrolysis. Absorption begins as a loss of tensile strength followed by a loss of mass. The retention strength of POLIGLECAPRONE 25 suture is at least 50% of the initial strength after 7 days in vivo. Absorption of POLIGLECAPRONE 25 absorbable synthetic suture is essentially complete between 91 and 119 days.
- POLIGLECAPRONE 25 suture is a monofilament synthetic absorbable sterile surgical suture
- POLIGLECAPRONE 25 suture is available from USP size 6-0 to 1
- POLIGLECAPRONE 25 is non-allergenic, non-pyrogenic and elicits only a slight tissue reaction during absorption
- The retention strength of the POLIGLECAPRONE 25 suture is at least 50% of the initial strength after 7 days
- Absorption of POLIGLECAPRONE 25 is essentially complete by 91-119 days
DESCRIPTION
POLIGLECAPRONE 25 suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
INDICATIONS
POLIGLECAPRONE 25 sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
ACTIONS
POLIGLECAPRONE 25 suture is a monofilament which elicits a minimal acute inflammatory reaction in tissues and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of POLIGLECAPRONE 25 sutures occurs by means of hydrolysis. Absorption begins as a loss of tensile strength followed by a loss of mass. The retention strength of POLIGLECAPRONE 25 suture is at least 50% of the initial strength after 7 days in vivo. Absorption of POLIGLECAPRONE 25 absorbable synthetic suture is essentially complete between 91 and 119 days.
CONTRAINDICATIONS
This suture, being absorbable, should not be used where extended approximation of tissue under stress is required.
WARNINGS
Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing POLIGLECAPRONE 25 suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture for use in patients. The use of this suture may be Inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing.
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. As an absorbable suture, POLIGLECAPRONE 25 suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support.
PRECAUTIONS
Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with absorption. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion and delayed absorption may occur.
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.
POLIGLECAPRONE 25 suture knots must be properly placed to be secure. 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. The use of additional throws may be particularly appropriate when knotting monofilaments. Avoid prolonged exposure to elevated temperature.
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 synthetic absorbable sutures include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching, or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, 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.
HOW SUPPLIED
POLIGLECAPRONE 25 sutures are available as sterile, monofilament, dyed (violet) strands in a variety of lengths and USP sizes, with or without needles.
STORAGE
We recommend that the suture be stored under a low temperature(less than 25℃) and low humidity (less than 60% RH). The storage in the dry chamber or the refrigerator is the best condition. Avoid the direct sunlight, high temperature and humidity.
PRODUCT PACKAGING
Golnit absorbable 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 absorbable sutures are sterilized by validated ethylene oxide (EtO) sterilization system.
