STERILE NON-ABSORBABLE POLYESTER SURGICAL SUTURE U.S.P
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”.
Procare® sutures are intended for use in orthopaedic, general and ophthalmic surgery.
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.
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 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.
The use of this suture is contraindicated in patients with known sensitivities or allergies to polyester and silicone.
- 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.
- 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.
- 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 or illness.
- Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
- 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.
- Avoid crushing or crimping damage due to surgical instruments such as forceps or needle holders.
- 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.
- The use of addition throws is particularly appropriate when knotting Procare®
- 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.
- Grasping in the sharp 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 used needles appropriately.
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.
Procare® 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.