Absorbable Surgical Suture, Polyglycolic Acid and Caprolactone (PGCL), USP 5/0, Reverse Cutting Needle 3/8 Circle, 16 mm, 75 cm Thread, 12 Pieces

The ALCALACTONE absorbable surgical suture is a sterile, synthetic monofilament made from a PGCL copolymer, composed of 75% polyglycolic acid and 25% caprolactone. The violet thread is 75 cm long and has a USP size of 5/0. It is attached to a 16 mm reverse cutting needle with a 3/8-circle curvature. The suture is sterilized with ethylene oxide (EO) and absorbed through hydrolysis.

The suture is intended for surgical ligation and soft tissue approximation. According to the manufacturer's data, it retains approximately 60% to 70% of its initial tensile strength after one week and more than 30% to 40% after two weeks. The wound support period is approximately 21 days, and absorption is essentially complete within 90 to 120 days. The material produces minimal acute inflammatory tissue reaction. These timeframes may vary depending on the tissue and biological conditions.

Characteristics:
• Composition: 75% polyglycolic acid and 25% caprolactone (PGCL)
• Thread structure: monofilament
• Color: violet
• Suture size: USP 5/0
• Thread length: 75 cm
• Needle: reverse cutting, 3/8-circle curvature, 16 mm
• Sterilization: ethylene oxide (EO)
• Absorption: through hydrolysis, within 90 to 120 days
• Wound support period: approximately 21 days
• Compliance: applicable USP and EP requirements for synthetic absorbable surgical sutures, according to the manufacturer

Applications:
• Surgical ligation
• Soft tissue approximation and fixation
• General surgery
• Dermatology and plastic surgery
• Gynecology
• Gastrointestinal surgery
• Urology

The suture is not intended for situations requiring prolonged tissue support.

Instructions for Use:
• The product must be used by qualified medical professionals following appropriate surgical techniques.
• Check the packaging integrity and expiration date. Do not use if the package is opened or damaged, or if the product has expired.
• Handle the thread and needle carefully to prevent damage. Use a suitable needle holder and appropriate knot-tying techniques.
• For contaminated or infected wounds, follow appropriate surgical procedures.
• During procedures involving the urinary or biliary tracts, avoid prolonged contact with urine, bile, or saline solutions, as calculus formation may occur.
• Assess the need for additional support in areas subject to tension, stretching, expansion, or dilation. Absorption may be delayed in tissues with a poor blood supply.
• Safety and effectiveness have not been established for use in neural or cardiovascular tissue or in microsurgery.
• Do not resterilize. Dispose of unused sutures and used needles in accordance with applicable procedures.

Adverse Reactions and Precautions:
Potential adverse reactions include wound dehiscence, inadequate tissue support, infection, local inflammatory reaction, irritation, erythema, induration, suture extrusion, and delayed absorption. Prolonged contact with urine, bile, or saline solutions may contribute to calculus formation. Needle breakage and accidental needlestick injuries involving contaminated needles are additional risks.

Localized irritation may occur if cutaneous sutures remain in place for more than 7 days.

Package Contents:
• 12 sterile ALCALACTONE surgical sutures, each with a violet PGCL monofilament thread, USP 5/0, 75 cm long, and a 16 mm reverse cutting needle with a 3/8-circle curvature.

The ALCALACTONE absorbable surgical suture is intended for professional use in surgical ligation and soft tissue approximation.