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Polyester Sutures | ProcarePolyester Suture

PROCARE - Polyester Suture

Procare is the brand name of polyester sutures manufactured by Dolphin Sutures.

 

Polyester suture is a braided and coated suture (silicone) and is a non-absorbable suture composed of Polyethylene terephthalate fiber.

 

Polyester sutures have excellent tensile strength, soft and pliable with excellent braiding and are an excellent choice for cardiovascular and ophthalmic surgery. Polyester sutures are not subject to degradation and retain tensile strength indefinitely in vivo.

 

Polyester sutures are available in green and white colours.

 

   Instructions for Use

 

  • Polyester suture is a coated and braided non-absorbable surgical suture. Polyester sutures are available with silicone or PTFE coating (on demand only).
  • Polyester sutures are available from U.S.P. size 5 to size 6-0. Sutures are available in green, white and black colours.
  • Polyester sutures are composed of polyester which is a category of polymers which contain the ester functional group in their main chain.
  • Polyester sutures are used for permanent, removable fixtures, cardiovascular surgery.
  • Our Polyester sutures are coated with silicon which facilitates the easy passage through the tissues.
  • Procare polyester sutures exhibit good knotting strength and secure knot placement.
  • Procare polyester sutures are available with needles made from 300 series alloy steel for superior strength, sharpness and performance.
  • Procare sutures are having excellent tensile strength and is ideal for cardiovascular surgery.

PROCARE ®

STERILE NON-ABSORBABLE POLYESTER SURGICAL SUTURE U.S.P

 

DESCRIPTION

Procare® suture is made of fine filaments of polyethylene terephthalate fiber braided to produce suture that remains soft & pliable, coated with silicone. Procare® sutures are dyed with D&C Green No. 5, usfda approval number §74.1205. The suture is also available in undyed form.

Procare® sutures are available in range of gauge sizes and lengths, non needled or 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. Procare® complies with the requirements of the United States Pharmacopoeia monograph for “Non-absorbable surgical suture”.

 

INTENDED USE

Procare® sutures are intended for use in orthopaedic, general and ophthalmic surgery.

 

SELECTION CRITERIA

The suture should be selected and implanted depending on patient’s condition, surgical experience, surgical technique, and wound size. Normally the skin sutures are removed within 30 days depending on wound condition. The decision of doctor is final in removing the skin sutures.

 

PERFORMANCE

Procure sutures elicit a minimal acute inflammatory reaction in tissues, followed by a gradual encapsulation of the sutures by fibrous connective tissues. Implantation studies in animals have shown no meaningful decline in the tensile strength over a period of time. Polyester sutures are pharmacologically inactive.

 

ADVERSE REACTIONS

Adverse reactions associated with the use of Procare® Suture include transitory local irritation at the wound site or transitory inflammatory foreign body response. Like all foreign bodies Procare® may potentate an existing infection.

 

CONTRAINDICATIONS

The use of this suture is contraindicated in patients with known sensitivities or allergies to polyester and silicone.

 

WARNINGS

  1. Surgeons should be familiar with surgical procedures and techniques involving non-absorbable sutures before employing polyester 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. 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.
  4. 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.
  5. Contamination of the device may lead to injury or illness.

 

PRECAUTIONS

  1. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
  2. In handling this suture material, care should be taken to avoid damaging the surface of the material with surgical instruments as this could lead to fracture of the material in use.
  3. Avoid crushing or crimping damage due to surgical instruments such as forceps or needle holders.
  4. Adequate knot security requires the standard surgical technique of flat and square ties with additional throws as indicated by surgical circumstances and the experience of the surgeon.
  5. The use of addition throws is particularly appropriate when knotting Procare® sutures.
  6. Care should be taken to avoid damage while handling surgical needle, Grasp the needle in an area of one third (1/3) to one half (1/2) of the distance from the attachment end to the sharp point.
  7. Grasping in the sharp point area could impair the penetration performance and cause fracture of the needle.
  8. Grasping at the butt or attachment end could cause bending or breakage.
  9. Reshaping the needles may cause them to loose strength and make less resistant to bending and breaking.
  10. Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury.
  11. Discard the used needles appropriately.

 

ADVERSE REACTIONS

Adverse reactions associated with the use of Procare® sutures include transitory local irritation at the wound site or transitory inflammatory foreign body response. Like all foreign bodies Procare® sutures may potentate an existing infection.

 

STERILITY

Procare® 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.

  • Polyester 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
  • 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