PGA
Instructions for use
Synthetic, absorbable, braided, multifilament, purple, surgical suture material made from polyglycolic acid, coated with polycaprolactone and calcium stearate.
description
The surgical suture material PGA is a synthetic, absorbable surgical suture material,
composed of a given number of braided fibers of polyglycolic acid,
whose molecular formula is (CH2CO)n. The PGA suture is coated with a polycaprolactone and calcium stearate. This suture material is available in a violet colour. The number of fibers used depends on the desired diameter of the end product.
This suture material is available in a variety of diameter and length combinations to accommodate needles of various sizes and types made from high quality medical grade stainless steel. The different combinations are described in detail in the catalogue.
The PGA surgical suture material is manufactured in accordance with the standards of the European Pharmacopoeia and the basic requirements of Directive 93/42/EEC
application areas
PGA synthetic absorbable surgical suture is for general purpose soft tissue fixation in contact. But its use is not indicated for the tissues of the central cardiovascular and central nervous system.
application
The synthetic, absorbable, surgical suture material PGA is used depending on the patient's condition,
wound size and tissue as well as surgical experience and technique.
Effect
After its implantation, the synthetic, absorbable, surgical suture PGA causes a moderate local inflammation of the tissue, as normal reaction to a foreign body, which is followed by a gradual encapsulation in a cyst of fibrous connective tissue. There follows a gradual loss of strength and volume of the suture due to resorption via the mechanism of hydrolysis, during which the polymer breaks down into glycolic acid, which is then resorbed and metabolized from body to body. In the first phase of resorption, a gradual loss of suture strength is observed without a corresponding significant loss in volume. The PGA suture has a residual strength greater than 65% according to the European Pharmacopoeia requirement at the end of the second week after implantation and over 35% approximately at the end of the third week. The suture material is absorbed within 60 to 90 days.
Contraindications
Synthetic, resorbable, surgical suture PGA should not be used in cases where prolonged retention of suture strength is necessary.
Warnings / Precautions / Interactions
PGA surgical suture material may only be used by members of specialized surgical teams.
Users must be familiar with procedures and techniques for handling absorbed sutures,
as the risk of wound dehiscence or wound rupture may vary depending on the location of the wound and the suture material used.
The well-established technique of flat and square knots is required for adequate security of the knots,
which is repeated depending on the nature of the case and the experience of the surgeon.
In any case, unnecessary stretching must be avoided to limit the likelihood of superficial wear or weakening of the seam. In addition, damage to the suture through its contact with surgical instruments must be avoided. The needle must be grasped by the needle holder within 1/3 to 1/2 of its total length from the armored end to the needle point.
Grasping the needle in the area of the needle tip can severely impair the penetration effect and lead to the needle breaking. Attempting to restore a bent needle to its original shape can cause severe loss of stability and reduced resistance to breakage. Used needles must be disposed of in a sharps container.
When selecting a suture, its performance in vivo must be taken into account. The suture may not be suitable for use in debilitated, infirm, or elderly patients, or in patients who are under the influence of circumstances that delay wound healing. Furthermore, the rate of degradation may vary according to tissue type (ie oral cavity).
The suture for topical application to the skin, which must remain in place for more than 7 days, may possibly cause local inflammation while the protruding part must be cut or removed.
side effects
Use of this suture may cause an allergic reaction or local transient inflammation in some patients, which is then followed by a transient inflammatory response. Also, like all foreign bodies, it can increase pre-existing inflammation.
sterilization
PGA synthetic absorbable surgical sutures have been sterilized with ethylene oxide gas. It is intended for single use only and must not be used if its packaging is open or damaged. Sutures that have been removed from their packaging and have not been used must be discarded. The surgical suture material must never be resterilized.
storage
Storage at ambient temperatures below 25°C, protected from moisture and direct exposure to heat, is recommended. It must never be used after the expiry date.
Explanation of the symbols on the packaging
The product has been manufactured in accordance with the requirements of the European Community Directive 93/42 on medical devices. CE mark and identification number of the testing agency involved.