PDO-2   POLYDIOXANONE SUTURE
SYNTHETIC ABSORBABLE MONOFILAMENT SUTURES, U.S.P/ Eur.Ph

DESCRIPTION
PD0-2 (polydioxanone) monofilament synthetic absorbable suture is prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)x. PDO-2 sutures are dyed violet (solvent violet 13 D&C No:2  C.I.60725) to enhance visibility in tissue.
Polydioxanone polymer has been found to be nonantigenic nonpyrogenic, and elicits only a slight tissue reaction during absorption.


INDICATIONS
PDO-2 monofilament synthetic absorbable sutures are ndicated for use in all types of soft tissue approximation, including use in paediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO-2 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.


ACTIONS
PDO-2 synthetic absorbable suture has been formulated to provide wound support through an extended healing period.
The results of implantation studies of PDO-2 monofilament suture in animals indicate that approximately 70% of its original strength remains two weeks after implantation. At four weeks post-implantation, approximately 50% of its original strength is retained, and at six weeks, approximately 25% of the original strength is retained. Absorption is essentially complete within six months.


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 PDO-2 (polydioxanone) sutures have not been established in neural tissue, adult cardiovascular tissue, or for use in microsurgery.
Under certain circumstances, notably orthopaedic procedures immobilization by external support may be employed at the discretion of the surgeon. Do not resterilize.


PRECAUTIONS
The PDO-2 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
Due to prolonged suture absorption, some irritation and bleeding has been observed in the conjunctive and mild Irritation has been observed in the
Vaginal mucosa.


HOW SUPPLIED                                      
PDO-2 sutures are available as sterile, monofilament, dyed (violet) strands in sizes 7/0 thru 2 (metric sizes 0.5 - 5.0), and sterile, in a variety of lengths, with a variety of needles.
PDO-2 clear suture strands are available in a variety of lengths with permanently attached needles.


STORAGE
Store below 25oC, Keep away from, sunlight.
Protect from humidity.
Do not use after expiry date.