Description

The MONOCRYL™ Plus Antibacterial Absorbable Suture by Ethicon is a highly specialized surgical tool designed for effective wound management. Crafted from Poliglecaprone 25, this monofilament suture is engineered to be absorbable, providing reliable performance without the need for removal. Its antibacterial properties are enhanced by Triclosan (Irgacare® MP), which helps inhibit bacterial colonization from pathogens such as Staphylococcus aureus and Escherichia coli, reducing the risk of surgical site infections.

Key Features

• Absorbable Monofilament: The suture's monofilament structure ensures smooth passage through tissue, minimizing trauma and promoting healing.
• Antibacterial Protection: Embedded with Triclosan, offering broad-spectrum antibacterial protection.
• Color Options: Available in undyed or violet, dyed with D&C Violet No.2, to suit various surgical needs.
• Sterilization: Sterilized using ethylene oxide gas for optimal safety.

Performance and Absorption

• Tensile Strength: Retains tensile strength for 21 to 28 days, with complete absorption through hydrolysis within 90 to 120 days.
• Inflammatory Response: Designed to provoke minimal initial inflammatory reaction, making it suitable for general soft tissue approximation and ligation.

Configurations

The suture is available in various gauge sizes and lengths, with options for non-needled or needled configurations. Needles are crafted from stainless steel and may feature CONTROL RELEASE™ technology for enhanced handling. Example configurations include:

• Size 4-0, 45cm Length: Equipped with a PS-2 needle (19mm, cutting edge prime reverse), available in boxes of 12.
• Size 5-0, 27 Inches Length: Undyed with a silver RB-1 taper point needle (17mm), available in boxes of 36.

Contraindications and Precautions

• Not Suitable For: Extended tissue approximation, closure of fascial tissue with undyed sutures, or use in patients with Triclosan allergy.
• Single Use Only: Do not resterilize or reuse. Store at or below 25°C (77°F).
• Packaging Integrity: Ensure packages are unopened to maintain sterility.

Potential Adverse Reactions

• Wound dehiscence
• Local irritation
• Suture extrusion
• Allergic reactions to Triclosan

Regulatory Information

The MONOCRYL™ Plus Suture is CE marked under the Medical Device Directive 93/42/EEC, ensuring compliance with European safety and performance standards. Packaging includes essential details such as use-by date, catalogue number, and batch number, providing comprehensive traceability for healthcare providers.