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

Enhance your surgical procedures with PRIMA Polyglycolic Acid Surgical Suture with Purple Thread, 75cm long and 20mm long, USP 2/0 diameter 1/2 circle atraumatic round needle, available in packs of 12. This high-quality product is built to meet your surgical needs with efficiency and safety.
Suture sizes are typically indicated using the USP (United States Pharmacopeia) system. This numbering system can be a little confusing, but it centers around suture “0”. Suture sizes increase from USP size 0 (“zero”) to size 1, commonly called “number 1”, to USP size 2 (“number 2”) and up.
Polyglycolic Acid Suture (polyglycolic acid) is a sterile, synthetic, multifilament, braided, absorbable surgical suture made from 100% glycolide homopolymers. POLYGLYCOLIC ACID suture is dyed with D&C Violet No. 2 (in accordance with the U.S. Code of Federal Regulations). POLYGLYCOLIC ACID suture is also available in an undyed form. For additional lubrication, smooth passage through tissue, and easy knot tying, POLYGLYCOLIC ACID suture is coated with a mixture of polycaprolactone and calcium stearate. POLYGLYCOLIC ACID suture is non-antigenic, non-pyrogenic, and causes only a mild tissue reaction during the absorption process. The composition of the dyed version of the polyglycolic acid suture is 96.1% - 99.2% polyglycolic acid, 0.4% - 2.2% polycaprolactone, 0.2% - 1.5% calcium stearate, and < 0.2% D&C Violet No. 2. The composition of the undyed version of the polyglycolic acid suture is 96.3% - 99.4% polyglycolic acid, 0.4% - 2.2% polycaprolactone and 0.2% - 1.5% calcium stearate. POLYGLYCOLIC ACID sutures comply with the requirements set by the European Pharmacopoeia (E.P) for sterile and absorbable synthetic braided sutures and by the United States Pharmacopoeia (U.S. P) for absorbable (synthetic) surgical suture.
INTENDED USE: Polyglycolic Acid Suture is intended for use in general soft tissue approximation and/or ligation, including use in plastic and ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
INDICATIONS: Indicated in surgical procedures where a combination of absorbable suture and short-term support is required for wound closure, approximation, and/or ligation of soft tissue.
CONTRAINDICATIONS: Polyglycolic Acid Suture, being absorbable, should not be used where extensive tissue approximation is required.
USERS: Only trained and registered healthcare professionals.
TARGETED PATIENT POPULATION: This suture may be used in patients of all ages and genders, in accordance with the intended use, indications, and contraindications.
PERFORMANCE: Polyglycolic acid suture after implantation causes an initial mild inflammatory reaction in the tissues and is eventually replaced by fibrous connective tissue growth. Polyglycolic acid suture, being absorbable in nature, is absorbed into the tissues by hydrolysis, during which the polyglycolic acid polymer is degraded to glycolic acid, which is ultimately absorbed and metabolized in the body. This absorption process initially leads to a progressive loss of tensile strength, followed by a loss of mass. Implantation studies in rats indicate that, following implantation, the approximate percentage of initial strength remaining for polyglycolic acid suture is 82% at 14 days, 56% at 21 days, and 20% at 28 days, and complete absorption of the suture essentially occurs in approximately 90 days.
APPLICATION: The suture should be selected and implanted depending on the patient's condition, surgical experience, surgical technique, and wound size.
WARNINGS
• This suture is intended for use by a qualified and registered healthcare professional.
• Users should be familiar with surgical procedures and surgical suturing techniques involving absorbable sutures before using polyglycolic acid suture for wound closure, as the risk of wound dehiscence may vary depending on the site of application and the suture material used. Users should consider in vivo performance when selecting a suture type.
• Users should use professional judgment in determining the appropriate suture size based on the specific indication, wound size, preferred surgical technique, patient condition, and history.
• Use of this suture type may be inappropriate in elderly, malnourished, or debilitated patients, or in patients with conditions that may delay wound healing.
• As with any foreign body, prolonged contact of this suture with saline solutions, such as those found in the urinary or biliary tract, may lead to the formation of stones.
• As an absorbable suture, it may act transiently as a foreign body, and, as with any foreign body, the presence of bacterial contamination may increase bacterial infectivity. Therefore, proper surgical practice should be followed regarding drainage and closure of infected or contaminated wounds.
• Wound dehiscence may occur when the suture fails to provide adequate support of the wound when closing areas where expansion, stretching, or distension occurs. Therefore, the user should consider the use of additional non-absorbable suture when closing areas that may undergo expansion, stretching, or distension, or that may require additional support.
• In certain circumstances, particularly in the case of orthopedic procedures, immobilization by external support may be used at the discretion of the user.
• It should be considered that suture extrusion and delayed absorption may occur when absorbable sutures are used in tissues with reduced blood flow.
• Conjunctival, cuticular, and vaginal epithelial sutures that remain in place for prolonged periods may be associated with localized irritation and should be trimmed or removed as indicated.
• Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with the absorption process. PRECAUTIONS: Care should be taken to avoid damage when handling surgical needles. Grip the needle in an area between one-third (1/3) and one-half (1/2) of the distance from the fixation end to the tip. Grasping at the tip may impair penetration performance and cause needle breakage. Grasping at the head or fixation end may cause the needle to bend or break. Reshaping of needles may result in loss of strength and make them less resistant to bending and breakage. Broken needles may result in prolonged or additional surgery or residual foreign bodies.
• Users should exercise caution when handling surgical needles to avoid unintentional needle stick injury. Dispose of used needles in "Sharps" containers.
• Care should be taken when handling this suture to avoid damage from handling. Avoid damage from crushing or crushing from the application of surgical instruments, such as forceps or needle holders.
• When necessary, straighten sutures with a gentle pull, without crushing or rubbing.
• As with any suture material, adequate knot security requires proper surgical techniques for tying with flat and square knots, with additional knots as warranted by the surgical circumstances and the user's experience.
• Do not tie tape around suture bags/packages, as this may damage the bags/packages.
• Do not resterilize, do not reuse. Reuse of this device (or portions of this device) may create a risk of product degradation, which may lead to device failure and/or cross-contamination, which may lead to infection or transmission of bloodborne pathogens to patients and users.
SIDE EFFECTS: Side effects associated with the use of polyglycolic acid suture include allergic response in some patients, transient local irritation at the wound site, transient foreign body inflammatory response, mild tissue inflammatory reaction, erythema and induration during the absorption process of subcuticular sutures, and, rarely, wound dehiscence. Like all foreign bodies, polyglycolic acid suture may exacerbate an existing infection.
CLINICAL BENEFITS: The clinical benefits of this type of suture are: its lubricating coating creates a smooth surface, thus reducing the coefficient of friction, allowing easy passage of tissue, and ensuring minimal/absolute tissue pulling and traumatization. The fact that it is braided ensures a secure knot-tying ability, compared to monofilament sutures. When used for approximation and/or ligature of tissues following an injury or surgery, it helps to close dead space, minimizes blood loss and infection, and also helps to heal wounds. When used for the approximation of skin edges, it provides an aesthetic and functional result. It provides adequate initial tensile strength according to U.S.P. and E.P. requirements. It provides adequate short-term support during the critical period of wound healing, even with smaller diameter sutures. It has a predictable absorption rate that allows decisions to be made regarding the application of sutures in relevant tissues and conditions, unlike natural sutures such as catgut, which do not have a predictable absorption rate. It is absorbed through the hydrolysis process, allowing for a mild tissue reaction and inflammatory response. This suture, being absorbable in nature, eliminates the discomfort of removing sutures, unlike non-absorbable sutures, thus saving the surgeon's time and decreasing patient anxiety and discomfort.
STERILITY: Polyglycolic acid suture is sterilized with ethylene oxide gas. Do not resterilize, do not reuse. Do not use if the package is opened or damaged. Discard opened, unused sutures.
STORAGE: Recommended storage conditions: Below 30° C, away from moisture and direct sunlight. Do not use after the expiration date.
Discover now the benefits of PRIMA polyglycolic acid surgical suture and offer your patients the best surgical closure solutions.