PRIMA Polyglycolic Acid Surgical Suture 75 cm, 1/2 Circle Round Needle 20 mm, USP 2/0

Product details

PRIMA polyglycolic acid surgical suture is an absorbable, synthetic, sterile suture intended for use in surgical procedures for general soft tissue approximation and ligation. It is indicated for procedures requiring a combination of short-term absorbable support for wound closure and must be used only by qualified healthcare professionals.

Technical specifications

• Material: Polyglycolic acid (100% glycolide homopolymers)
• Length: 75 cm
• Needle: Atraumatic round, 1/2 circle, 20 mm
• USP size: 2/0
• Color: Violet (D&C Violet No. 2)
• Structure: Braided multifilament
• Coating: Blend of polycaprolactone and calcium stearate for added lubrication and ease of knot tying
• Dyed version composition: 96.1% - 99.2% polyglycolic acid, 0.4% - 2.2% polycaprolactone, 0.2% - 1.5% calcium stearate, <0.2% D&C Violet No. 2
• Compliance: European Pharmacopoeia (E.P.) and United States Pharmacopeia (U.S.P.) for sterile synthetic absorbable braided sutures
• Biocompatibility: Non-antigenic, non-pyrogenic, mild tissue reaction during absorption

Performance and absorption

• Tensile strength after implantation: approximately 82% at 14 days, 56% at 21 days, 20% at 28 days
• Complete absorption: approximately 90 days
• Absorption mechanism: Hydrolysis in tissues, degradation into glycolic acid, metabolized by the body
• Initial process: Progressive loss of tensile strength, followed by loss of mass

Indications for use

• Wound closure in general surgical procedures
• Soft tissue approximation and ligation
• Plastic and ophthalmic procedures
• Situations requiring short-term absorbable support

Contraindications

• Not indicated where extended tissue approximation is required
• Must not be used in cardiovascular and neurological tissues
• Elderly, malnourished or debilitated patients with delayed healing
• Patients with conditions that may delay wound healing

Package contents

• Quantity per case: 50 pcs
• Retail package: 12 pcs

Directions for use

The suture should be selected and implanted according to the patient's condition, surgical experience, surgical technique and wound size. Users should be familiar with surgical procedures and suturing techniques involving absorbable sutures before use.

Warnings and precautions

• Use is restricted to qualified and registered healthcare professionals only
• The risk of wound dehiscence may vary depending on the application site and the material used
• When selecting the suture size, consider the specific indication, wound size, preferred surgical technique and the patient's condition
• Prolonged contact with saline solutions (urinary or biliary tract) may lead to calculus formation
• The presence of bacterial contamination may increase infectivity; follow appropriate surgical practice for drainage and closure of infected or contaminated wounds
• In areas subject to expansion, stretching or distension, the use of additional non-absorbable sutures is recommended
• In tissues with poor blood supply, extrusion and delayed absorption may occur
• Conjunctival, cuticular and vaginal epithelial sutures left in place for extended periods may cause localized irritation and should be cut or removed
• Subcuticular sutures should be placed as deep as possible to minimize erythema and induration
• Avoid damaging the needle during handling: grasp it in an area between 1/3 and 1/2 of the distance from the attachment end to the point
• Grasping near the point impairs penetration and may cause the needle to break
• Grasping at the swage or attachment end may cause the needle to bend or break
• Reshaping needles causes loss of strength and increases the risk of breakage
• Broken needles may result in prolonged or additional surgical procedures and residual foreign bodies
• Exercise caution when handling surgical needles to avoid inadvertent needlestick injuries
• Dispose of used needles in designated medical waste containers