PGLA RAPID sutures
Coated PGLA Rapid suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular PGLA (polyglactin 910) suture.
PGLA Rapid are obtained by coating the braided suture material with a copolymer composed of 90% caprolactone and 10% glycolide followed by a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) and calcium stearate of vegetable origin. The copolymers used in this product have been found to be non-antigenic, non-pyrogenic and elicit only a mild tissue reaction during absorption. The sutures are available dyed and undyed (natural).Progressive loss of tensile strength and eventual absorption of PGLA Rapid occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic acids that are subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile strength followed by a loss of mass. The retention strength of PGLA Rapid is about 45% of the initial strength after 7 days. The absorption of PGLA Rapid is essentially complete by 42 days.
- PGLA Rapid suture is a synthetic absorbable sterile surgical suture
- Available from USP size 7-0 to 2
- The copolymers used in this product have been found to be non-antigenic, non-pyrogenic and elicit only a mild tissue reaction during absorption
- The retention strength of PGLA Rapid is about 45% of the initial strength after 7 days. The absorption of PGLA Rapid is essentially complete by 42 days
DESCRIPTION
Coated PGLA Rapid suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular PGLA (polyglactin 910) suture.
PGLA Rapid are obtained by coating the braided suture material with a copolymer composed of 90% caprolactone and 10% glycolide followed by a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) and calcium stearate. The copolymers used in this product have been found to be non-antigenic, non-pyrogenic and elicit only a mild tissue reaction during absorption.
The sutures are available dyed and undyed (natural).
PGLA Rapid is available in a range of gauge sizes and lengths, without needles or attached to a stainless steel needles of varying types and sizes. The knot tensile strength of PGLA Rapid meets USP requirements for collagen sutures.
INDICATIONS
Coated PGLA Rapid suture is intended for use in soft tissue approximation where only short term wound support is required and where the rapid absorption of the suture would be beneficial. Due to its absorption profile PGLA Rapid is useful for skin closure, particularly in pediatric surgery, episiotomies, circumcision and closure of oral mucosa. PGLA Rapid is also successfully used in ophthalmic surgery for conjunctival sutures.
APPLICATION
Sutures should be selected and implanted depending on patient condition, surgical experience, surgical technique and wound size. PGLA Rapid typically falls off 7-10 days post-operatively or can be wiped off subsequently with sterile gauze. Normally the removal of the suture is not required.
PERFORMANCE
PGLA Rapid suture elicits a minimal to moderate initial inflammatory tissue reaction. Progressive loss of tensile strength and eventual absorption of PGLA Rapid occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic acids that are subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile strength followed by a loss of mass. The retention strength of PGLA Rapid is about 45% of the initial strength after 7 days at 37 degrees by Celsius. The absorption of PGLA Rapid is essentially complete by 42 days.
CONTRAINDICATIONS
Due to the rapid loss of tensile strength, PGLA Rapid should not be used where extended approximation of tissues under stress is required or where wound support or ligation beyond 7 days is required. PGLA Rapid suture is not for use in cardiovascular or neurological tissues.
WARNINGS/PRECAUTIONS/INTERACTIONS
Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Coated PGLA Rapid 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 PERFORMANCE section) when selecting a suture.
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, PGLA Rapid 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.
Skin sutures that stay in place for more than 7 days may cause localized irritation and should be snipped off or removed as indicated.
Consideration should be taken in the use of of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with the absorption process.
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.
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.
Coated PGLA Rapid sutures, which are treated to enhance handling characteristics, require 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” container. Do not re-sterilize/reuse. Reuse of the device (or portions of the device) may create a risk of product degradation, which may result in device failure and/or cross-contamination, which may lead to infection or transmission of blood-borne pathogens to patients and users.
Avoid prolonged exposure to elevated temperatures.
Discard opened packages and unused sutures.
ADVERSE REACTIONS
Adverse effects associated with the use of this device include transient local irritation at the wound site, transitory inflammatory foreign body response, erythema and induration during the absorption process of subcuticular sutures. Like all foreign bodies, PGLA Rapid may enhance an existing infection.
STORAGE
Recommended storage conditions: Below 25 °C, away from moisture and direct heat. Do not use after expire date!
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.
METHODS OF STERILIZATION
Golnit absorbable sutures are sterilized by validated ethylene oxide (EtO) sterilization system.
