PEGELAK rapid sutures are synthetic absorbable sterile surgical sutures which are flexible strands composed of a copolymer prepared and synthesized from 90 percent glycolide and 10 percent L-lactide (derived from glycolic and lactic acids) and are indicated for use in soft tissue approximation.
The empirical formula of the copolymer is –[(C2H2O2)x(C3H4O2)y] n – where, x:y=9:1. The braid structure of the suture is coated. Coated suture is prepared by coating suture material with a mixture composed of equal parts of calcium stearate and poly(glycolide-co-L-lactide) [Glacomer 37] (–[(C2H2O2)x(C3H4O2)y] n – where, x:y=3:7).
PEGELAK rapid sutures when introduced into a living organism are absorbed by that organism and cause no undue tissue irritation. Copolymer and the coating with calcium stearate have been found to be non-antigenic, non-pyrogenic, and elicit only a mild tissue reaction during absorption.
PEGELAK rapid is the lower molecular weight form of PEGELAK, which enables rapid hydrolysis/absorption.
The sutures are undyed (natural, beige).
PEGELAK rapid complies with the requirements of the United States Pharmacopoeia (USP) for absorbable surgical suture and the European Pharmacopoeia (EP) for sterile synthetic absorbable braided suture (except for occasional slight oversize in some gauges).
PEGELAK rapid is indicated only for use in soft tissue approximation where only short term wound support (7-10 days) is required including ophthalmic surgery. PEGELAK rapid is not indicated for use in cardiovascular and neurological tissues.
Sutures are for single use only.
PEGELAK rapid sutures elicit a minimal acute inflammatory reaction in tissue and ingrowth of fibrous connective tissue. Gradual progressive loss of tensile strength and eventual absorption of sutures occur by means of hydrolysis and suture degrades to glycolic and lactic acids which are metabolized in the body.
Absorption process begins a loss of tensile strength followed by a loss of mass. Absorption test in rats and in vitro hydrolysis show that PEGELAK rapid suture retains a minimum of 50% knot strength at 5 days. All of the original tensile strength of PEGELAK rapid is essentially lost by 10-14 days post implantation. Mass absorption of Pegelak rapid takes place after approximately 42 days.
PEGELAK rapidsutures are available as sterile, braided, dyed (violet or green) and undyed (natural) strands in sizes USP 6/0 - USP 2 (metric sizes 0.7 - 5), in a variety of lengths, with or without various needles.
Sutures are available in one and two dozen boxes.
The product should be kept dry and clean. Store below 30ºC and keep away from direct sunlight and moisture. Do not use products after expiry (“use by”) date.
PEGELAK rapid should not be used where approximation of tissues beyond 7 days or wound support beyond 7 days is required.
Users should be familiar with surgical procedures and techniques before employing absorbable sutures for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material is used. Users should consider the in vivo performance, under ACTIONS section, when selecting a suture. 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.
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 this is an absorbable suture material; it may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
The use of supplemental non-absorbable 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.
As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice must be followed with respect to drainage, and closure of contaminated or infected wounds.
Sterility is preserved only when opened under sterile conditions.
Do not re-sterilize.
Store at room temperature and avoid prolonged exposure to elevated temperatures.
Discard opened packages and unused sutures. Do not use opened or damaged products.
This device is single use. Known hazards with reuse or re-sterilization of opened/original packages of the device are cross contamination, infection, early degradation, and trauma.
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.
Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.
Under some circumstances, notably orthopedic procedures, immobilization of joint by external support may be employed at the discretion of the surgeon.
Consideration should be taken in absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.
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, failure to provide adequate wound support in closure of the sites where expansion, stretching or distention occur, failure to provide adequate wound support in elderly malnourished, or debilitated patients, or in patients suffering form conditions which may delay wound healing, 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 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.
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.