Polydioxanone Sutures | DuracrylPolydioxanone Sutures | DuracrylPDS Suture

DURACRYL - PDS Suture

Duracryl is the brand name of polydioxanone sutures manufactured by Dolphin Sutures. Polydioxanone suture is a sterile monofilament synthetic absorbable suture composed of the polyester, poly (p-dioxanone).

 

Polydioxanone suture provides wound support for longer period as compared to other synthetic absorbable sutures. Polydioxanone suture also offers far superior tensile strength. Polydioxanone suture is made from polymerizing para dioxanone monomer. PDS sutures provide wound support for longer periods up to 50 days and offers far superior tensile strength and outstanding pliability. Its monofilament structure provides good handling properties and excellent knot security. Absorption of suture is by simple hydrolysis within 180 days from implantation day. Absorption of polydioxanone suture is reliable and predictable.

 

PDS sutures are ideal for use in general orthopaedic surgery, sub cuticular, gastro intestinal tract, paediatric cardiovascular surgery, sheath closure and general surgery. PDS sutures also cause minimal tissue reaction.

 

Polydioxanone suture is available in violet colour.

 

catalog   Instructions for Use

 

  • Polydioxanone suture is a synthetic, monofilament absorbable suture.
  • Polydioxanone sutures are available from U.S.P. size 2 to size 6-0. Sutures are available in violet colour.
  • Polydioxanone sutures are composed of polymers made from 100% homopolymer of polydioxanone.
  • Polydioxanone sutures absorb by simple hydrolytic mechanism and absorption is predictable.
  • Polydioxanone sutures retain about 70% of the initial tensile strength after 2 weeks, 50% of the initial tensile strength after 4 weeks and 25% after 6 weeks of implantation and the suture is essentially absorbed within 180 days.
  • Duracryl sutures pass through tissue easily causing very little trauma.
  • Duracryl sutures have good knot security and it has easy knot placement.
  • Duracryl sutures have the highest tensile strength compared to any other synthetic absorbable sutures and it is absorbed over a longer period of time hence can be used where long term tissue approximation is required.
  • Duracryl sutures are available with needles made from 300 series alloy steel for superior strength, sharpness and performance.

Brand name: DURACRYL

Material: Monofilament Polydioxanone
Synthetic Absorbable Sutures

Indications:
Polydioxanone monofilament synthetic absorbable sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. Polydioxanone suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Contraindications:
These sutures, being absorbable, are not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required and are not to be used in conjunction with prosthetic devices, i.e., heart valves or synthetic grafts.

Warnings:
The safety and effectiveness of Polydioxanone sutures have not been established in neural tissue, adult cardiovascular tissue or for use in microsurgery. Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon. Do not re-sterilize.

Precautions:
Polydioxanone suture knots must be properly placed to be secure. As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator. As with any suture, care should be taken to avoid damage when handling. Avoid the crushing or crimping application of surgical instruments, such as needle holders and forceps, to the strand except when grasping the free end of the suture during an instrument tie. Conjunctival and vaginal mucosal sutures remaining in place for extended periods may be associated with localized irritation and should be removed as indicated. Subcuticular sutures should be placed as deeply as possible in order to minimize the erythema and induration normally associated with absorption. Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.

Adverse reactions:
Adverse effects associated with the use of synthetic absorbable sutures include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching, or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of blood borne pathogens.

Sterility:
Polydioxanone 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 below 25 ºC, away from moisture and direct heat. Do not use after expiry date.

 

Symbols used on the labels:

IFU

 

  • Polydioxanone 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