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Pegelak®

PEGELAK® braided, poly(glycolide-co-lactide), synthetic, absorbable, multifilament, sterile surgical sutures

Pegelak® Doğsan Absorbable Surgical Suture

PEGELAK 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 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.

The sutures are coloured violet to enhance visibility in tissue. The suture is also available undyed (natural, beige).

PEGELAK 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).

INDICATIONS

PEGELAK is indicated for use in general soft tissue approximation and/or ligation including use ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

Sutures are for single use only.

ACTIONS

PEGELAK 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 begins as a loss of tensile strength followed by a loss of mass. Animal and in-vitro hydrolysis studies indicate that PEGELAK suture retains approximately 75% of the original tensile strength at two weeks post implantation. At three weeks, approximately 40% of the original strength is retained.  All of the original tensile strength is lost between four - five weeks post implantation and suture absorption is essentially complete between 56 to 70 days.

HOW SUPPLIED

PEGELAK sutures are available as sterile, braided, dyed (violet or green) and undyed (natural) strands in sizes USP 8/0 - USP 2 (metric sizes 0.4 - 5), in a variety of lengths, with or without various needles.

Sutures are available in one and two dozen boxes.

STORAGE

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.

CONTRAINDICATIONS

PEGELAK sutures, being absorbable, should not be used where extended approximation of tissue is required.

WARNINGS

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 resterilization of opened/original packages of the device are cross contamination, infection, early degradation, and trauma.”

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.

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 REACTIONS

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.

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