PRIMA Polyglycolic Acid Surgical Suture 75 cm, 1/2 Circle Round Needle 26 mm, USP 3/0

Product details

PRIMA polyglycolic acid surgical suture is an absorbable, synthetic, sterile suture intended for the closure, approximation and ligation of soft tissue in various surgical procedures. The product is indicated for healthcare professionals who require short-term wound support.

Technical Specifications

• Material: polyglycolic acid (100% glycolide homopolymer)
• Thread type: braided multifilament, absorbable, synthetic
• Color: violet (D&C Violet No. 2)
• Length: 75 cm
• USP size: 3/0
• Needle: atraumatic round-bodied, 1/2 circle, 26 mm
• Lubricant coating: blend of polycaprolactone and calcium stearate
• Composition (dyed version): polyglycolic acid 96.1%-99.2%, polycaprolactone 0.4%-2.2%, calcium stearate 0.2%-1.5%, D&C Violet No. 2 <0.2%
• Biological properties: non-antigenic, non-pyrogenic, mild tissue reaction during absorption

Compliance and Standards

• Complies with the European Pharmacopoeia (E.P.) for sterile synthetic absorbable braided sutures
• Complies with the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures

Available Sizes and Variants

• Packaging: 12 pcs per unit
• Quantity per case: 50 units

Applications

• General soft tissue closure and approximation
• Soft tissue ligation
• Plastic surgery procedures
• Ophthalmic procedures

Performance and Absorption

• After implantation, it causes a mild initial inflammatory reaction, followed by fibrous tissue ingrowth
• Absorption by hydrolysis: polyglycolic acid degrades into glycolic acid, which is absorbed and metabolized by the body
• Tensile strength retention: approximately 82% at 14 days, 56% at 21 days, 20% at 28 days
• Complete absorption: approximately 90 days

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 apply professional judgment in choosing the appropriate size. The needle should be grasped in an area between 1/3 and 1/2 of the distance from the attachment end to the point, to avoid impairing penetration performance and needle breakage.

Package Contents

• PRIMA polyglycolic acid surgical suture, 75 cm, with atraumatic round-bodied needle
• Packaging: 12 pcs

Indications

• Surgical procedures requiring the combination of an absorbable suture and short-term support for wound closure, approximation and/or ligation of soft tissue

Contraindications

• Not recommended for extended tissue approximation requiring long-term support
• Not for use in cardiovascular and neurological tissue
• Use may be inappropriate in elderly, malnourished or debilitated patients, or in those with conditions that may delay wound healing

Warnings and Precautions

• Intended for use by qualified, registered healthcare professionals
• Users should be familiar with surgical procedures and suturing techniques with absorbable sutures before use
• The risk of wound dehiscence may vary depending on the application site and the suture material used
• Prolonged contact with saline solutions (urinary or biliary tract) may lead to calculus formation
• The presence of bacterial contamination may increase bacterial infectivity; appropriate surgical practice should be followed for drainage and closure of infected or contaminated wounds
• Wound dehiscence may occur at sites subject to expansion, stretching or distension; the use of additional non-absorbable sutures is recommended if additional support is required
• In tissues with poor blood supply, suture extrusion and delayed absorption may occur
• Epithelial sutures left in place for extended periods may cause localized irritation and should be cut or removed as indicated
• Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration associated with absorption
• Avoid damaging the needle during handling; grasping in the point area may impair penetration and cause breakage
• Reshaping needles may cause loss of strength and increased brittleness
• Broken needles may result in prolonged or additional surgery and residual foreign bodies
• Exercise caution when handling surgical needles to avoid inadvertent needlestick injury
• Dispose of used needles in appropriate containers