Description
Suture Material Suture Material
Sterile absorbable synthetic sutures made of Poliglecaprone (PGCL), with or without needles. Poliglecaprone (PGCL) is non-antigenic and non-pyrogenic. These sutures are monofilament and can be obtained in both dyed (violet) and undyed (beige) variations. Poliglecaprone (PGCL) conforms to the requirements specified in the United States Pharmacopoeia (USP) for synthetic absorbable surgical sutures and the European Pharmacopoeia (EP) for sterile synthetic absorbable surgical sutures.
Instructions for Use Instructions for Use
It is used for general soft tissue approximation and should not be used for cardiovascular and neurological procedures.
Actions Actions
SurgeCAPRONE (Poliglecaprone) synthetic absorbable sutures are known to induce a minimal acute inflammatory reaction in tissues, which is later followed by the gradual formation of fibrous connective tissue around the suture.
The tensile strength of these sutures progressively decreases over time, and they are eventually absorbed through hydrolysis. The absorption process begins with a reduction in tensile strength, followed by a decrease in overall mass. Typically, complete absorption occurs within approximately 90 to 120 days.
SurgeCAPRONE (Poliglecaprone) synthetic absorbable sutures are available in sizes ranging from 2 to 6/0.
Characteristics Characteristics
Surgexon offers a rapid-absorbing material called Poliglecaprone, made from a synthetic absorbable monofilament comprising a copolymer of glycolide and e-caprolactone (PGCL). Surgexon provides Poliglecaprone in two color options: violet and colorless.
- Initially exhibits a remarkably high level of tensile strength.
- Demonstrates outstanding handling characteristics and exceptional flexibility.
- Exhibits a notably low occurrence of infections and trauma.
- Facilitates smooth passage through tissues.
- Ensures dependable absorption.
- Wound dehiscence: The opening of a closed wound.
- Inadequate wound support in areas where expansion, stretching, or distension may occur.
- Inadequate wound support in elderly, malnourished, or debilitated patients, as well as in patients with conditions that may delay wound healing.
- Wound infection: The presence of an infection in the wound.
- Minimal acute inflammatory tissue reaction: A mild response from the body's immune system at the wound site.
- Localized irritation when skin sutures are left in place for more than 7 days.
- Formation of calculi (stones) in the urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs.
- Transitory (temporary) local irritation.
Contraindications Contraindications
SurgeCAPRONE (Poliglecaprone) is a type of suture that is designed to be absorbable. It is recommended for use in situations where tissue support is required.
Warning Warning
The SurgeCAPRONE (Poliglecaprone) suture is sterilized using ethylene oxide gas specifically for single use. It is important not to re-sterilize the suture. If the package is opened or damaged, it should not be used. Any open, unused sutures should be discarded. The suture should be stored at room temperature and protected from prolonged exposure to high temperature and moisture. The selection and use of SurgeCAPRONE (Poliglecaprone) should be based on the patient's condition, the surgeon's experience, the surgical technique, the location of the wound, and the size of the wound. Requirements and techniques may vary depending on these factors and indications. Prior to using SurgeCAPRONE (Poliglecaprone) for wound closure, it is crucial for users to have a good understanding of surgical procedures and techniques involving absorbable sutures. The risk of wound dehiscence (the opening of a closed wound) can vary depending on the site of application and the type of suture material used. It is important to ensure that the suture thread is securely knotted, with a suggested length of more than 0.5mm for the end of the thread. The part of the needle that is intended to be held should not be changed, as any alteration may cause damage to the needle's point or sharp edge.
In elderly, malnourished, or debilitated patients, as well as in patients with conditions that may hinder wound healing, the effectiveness of SurgeCAPRONE (Poliglecaprone) may be diminished. Since it is an absorbable suture material, surgeons should contemplate the use of additional absorbable sutures in cases where the closure sites may experience expansion, stretching, distention, or require extra support.
Precautions Precautions
In certain situations, particularly in orthopedic procedures, the surgeon may choose to utilize external support for immobilization. Skin sutures that need to remain in place for more than 7 days may lead to localized irritation and should be removed as necessary. When handling Poliglecaprone (PGCL) sutures or any other suture materials, it is important to exercise caution to prevent damage during the handling process. Care should be taken to avoid crushing or crimping damage caused by the use of surgical instruments such as forceps or needle holders.
To ensure sufficient knot security, it is necessary to employ the recognized surgical technique of creating a flat, square knot with additional throws as deemed necessary based on the surgical situation and the surgeon's experience. The use of additional throws may be especially suitable when tying knots with monofilament sutures.
Adverse Reactions Adverse Reactions
The use of this device can lead to certain adverse effects, including:
It is important to be aware of and address these potential adverse effects when using this device.
Storage Storage
The packed product should be stored at a temperature not exceeding 40℃. It should be protected from moisture and direct heat. It is essential not to use the product after the expiration date has passed.
Brand Name Length Size
| Brand Name | Suture Material | Length | Size | ||||||||||
| SurgeCAP | Poliglecaprone25 |
|
|
