STERILE ABSORBABLE POLIGLECAPRONE 25 SURGICAL SUTURE U.S.P
PETCRYL® MONO suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. Poliglecaprone 25 copolymer has been found to be non-antigenic, non-pyrogenic and elicits only a slight tissue reaction during absorption. PETCRYL® MONO sutures are available in range of gauge sizes and lengths, attached to stainless steel needles of varying types, sizes and shapes. The needles are attached permanently to the suture. Entire details of the product range are available in the catalogue. The suture is available as an undyed and dyed violet. It is dyed violet with CI solvent Violet No. 13 (Color Index No. 60725)
PETCRYL® MONO sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
PETCRYL ® MONO sutures should be selected and implanted depending on the patient’s condition, surgical experience, surgical technique and wound size.
Petcryl® MONO suture leads to ingrowth of fibrous connective tissue due to minimal initial inflammatory tissue reaction. Petcryl® MONO gradually loses tensile strength and is finally absorbed by hydrolytic process. Absorption pattern for undyed suture when tested on rats:-
Approx 78.7 % of the tensile strength at 7 days,
Approx 39.6 % of tensile strength at 14 days,
Approx 15.0% tensile strength after 21 days and
Approx 4.4% tensile strength after 28 days.
Absorption pattern for dyed suture when tested on rats:-
Approx 68 % of the tensile strength at 7 days,
Aprox 41.3 % of tensile strength at 14 days,
Approx 11.7% tensile strength after 21 days and
Approx 3.3% tensile strength after 28 days.
Adverse reaction, associated with the use of the device include transitory local irritation at the wound site, transitory inflammatory foreign body response, erythema and induration during the absorption process of subcuticular sutures. Like all foreign bodies, Petcryl® MONO suture may enhance an existing infection.
Petcryl® MONO suture, being absorbable, should not be used where extended approximation of tissues under stress is required such as in fascia. The use of this suture is contraindicated in patients with known sensitivities or allergies to Poliglecaprone.
- Surgeons should be familiar with surgical procedures and techniques involving absorbable sutures before employing Petcryl®MONO suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.
- In surgery of the urinary or biliary tract, care should be taken to avoid prolonged contact of this or any other suture with salt solution, to prevent calculus formation.
- This suture many be inappropriate in patients suffering from conditions which may delay wound healing e.g., patient that are elder, malnourished or depilated. As this is an absorbable suture, the use of supplemental non-absorbable suture should be considered by the surgeon in the close of the abdomen, chest, joints or other sites subjects to expansion or requiring additional support.
- For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re‐sterilization may compromise the structural integrity of the device and/ or lead to device failure which, in turn, may result in patient injury or illness.
- Reuse, reprocessing or re‐sterilization may also create a risk of contamination of the device and/or cause patient infection or cross‐infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
- Contamination of the device may lead to injury, illness of the patient.
- Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
- Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.
- Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
- Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.
- Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration, normally associated with the absorption process.
- When handling this or any other suture, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.
- Care should be taken to avoid damage while handling surgical needles. Grasp the needle in an area, one third (1/3) to one half (1/2) of the distance from the attachment end to the point.
- Grasping in the point area could impair the penetration performance and cause fracture of the needle.
- Grasping at the butt or attachment end could cause bending or breakage.
- Reshaping the needles may cause them to loose strength and make less resistant to bending and breaking.
- Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury. Discard the needles after use.
Petcryl® MONO sutures are sterilized by ethylene oxide. Do not re – sterilize! Do not use if package is opened or damaged! Discard opened unused sutures.
Recommended storage condition 10oC-35°C, away from moisture and direct heat. Do not use after expiry date.
Discard used sutures and needles contaminated with blood in the container meant infectious waste. Unused expired pouches should be incinerated.