Poliglecaprone Sutures | Petcryl MonoPoliglecaprone 25 Sutures | Petcryl MonoPGCL Suture

PETCRYL MONO - Poliglecaprone 25 Suture

Petcryl Mono is the brand name of Poliglecaprone 25 sutures manufactured by Dolphin Sutures. Poliglecaprone suture is monofilament synthetic absorbable suture which is a copolymer of glycolide and caprolactone.

 

Petcryl Mono has low tissue reactivity and maintains 50 to 60% in-vivo tensile strength at 7 days and 20 to 30% at 14 days. Total absorption in tissues takes around 90 to 120 days. Being monofilament, the suture is smooth, making it easier to pass through the tissues as compared to braided suture. It has a consistency close to nylon suture material. The suture is rarely used for percutaneous skin closure and is not used in areas of high tension. Petcryl Mono is similar to Monocryl sutures and has similar absorption profile.

 

Poliglecaprone suture is generally used for soft-tissue approximation, subcuticular dermis closures of the face and as ligature. The suture is absorbed in tissues by simple hydrolysis and known for reliable absorption.

 

Poliglecaprone sutures are available in undyed and violet colour.

 

catalog   Instructions for Use

 

  • Poliglecaprone suture is a synthetic, monofilament absorbable suture.
  • Poliglecaprone sutures are available from U.S.P. size 1 to size 6-0. Sutures are available in undyed (beige-golden) and dark violet colour.
  • Poliglecaprone sutures are composed of polymers made from 100% homo polymer of Poly(glycolic-co-caprolactone) (PGCL). 
  • Poliglecaprone sutures absorb by simple hydrolytic mechanism and absorption is predictable.
  • Poliglecaprone sutures retain about 50 – 60 % of the initial tensile strength at 7 days, 20 – 30 % of the initial tensile strength at 14 days of implantation and the suture is essentially absorbed within 90  – 120 days of implantation.
  • Petcryl Mono sutures pass through the tissues easily and since the suture is monofilament knotting is very easy.
  • Petcryl Mono sutures have good knot security and easy knot placement.
  • Petcryl Mono sutures are available with needles made from 300 series alloy steel for superior strength, sharpness and performance.
  • Petcryl Mono sutures have excellent tensile strength and needle attachment strength.

 

PETCRYL® MONO

STERILE ABSORBABLE POLIGLECAPRONE 25 SURGICAL SUTURE U.S.P

 

DESCRIPTION

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)

 

INDICATIONS
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.

 

SELECTION CRITERIA

PETCRYL ® MONO sutures should be selected and implanted depending on the patient’s condition, surgical experience, surgical technique and wound size.

 

PERFORMANCE

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 REACTIONS

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.

 

CONTRAINDICATIONS
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.

 

WARNINGS

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Contamination of the device may lead to injury, illness of the patient.

 

PRECAUTIONS

  1. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
  2. Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.
  3. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
  4. Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.
  5. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration, normally associated with the absorption process.
  6. 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.
  7. 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.
  8. Grasping in the point area could impair the penetration performance and cause fracture of the needle.
  9. Grasping at the butt or attachment end could cause bending or breakage.
  10. Reshaping the needles may cause them to loose strength and make less resistant to bending and breaking.
  11. Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury. Discard the needles after use.

 

STERILITY

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.

 

STORAGE

Recommended storage condition 10oC-35°C, away from moisture and direct heat. Do not use after expiry date.

 

DISPOSAL

Discard used sutures and needles contaminated with blood in the container meant infectious waste. Unused expired pouches should be incinerated.

  • Poliglecaprone sutures are individually packed in a primary medical grade paper folder
  • Individually packed sutures are then packed in a tear-open or peel-open aluminum foil, with less than 300ppm moisture
  • Aluminum foils are further packed in a secondary medical grade paper pouch laminated with polyester laminated poly film
  • Sutures are further packed in small cartons made from premium 320 GSM Cyber XLPac in 12 suture pack
  • Boxes are further laminated in tamper proof film to protect it from dirt/dust
  • Further, the sutures are packed in an export worthy 7 ply master carton which can accommodate 100 boxes ( 70 x 30 x 30 cms) - weighing up to 9 to 10kg and 200 boxes ( 70 x 29 x 59 cms) - weighing up to 18kg