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