PEDESENTE is sterile synthetic, absorbable surgical monofilament suture. The suture is made of poly(p-dioxanone) and the empirical formula is (-O-CH2- CH2-OCH2-CO-)n. Polydioxanone polymer has been shown to be non-antigenic, non-pyrogenic and elicits only a slight tissue reaction during absorption.
PEDESENTE sutures are dyed by adding D&C Violet No.2 during polymerization to enhance visibility in tissue. The suture is also available undyed (natural, beige).
PEDESENTE meets all requirements for synthetic absorbable surgical monofilament sutures specified at the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).
PEDESENTE sutures are indicated for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. Sutures are for single use only.
PEDESENTE is not indicated in adult cardiovascular tissue, microsurgery and neural tissue.
PEDESENTE elicits a minimal initial inflammatory reaction in tissues and is eventually replaced with an in-growth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PEDESENTE sutures occurs by means of hydrolysis, where the polymer degrades to the monomers which are subsequently absorbed and eliminated by the body. Absorption begins as loss of tensile strength followed by a loss of mass. Studies show that approximately 75 % of the original strength is retained at two weeks after implantation. At four weeks post implantation, approximately 60 % of the original strength is retained. Absorption test in rats and in vitro hydrolysis of PEDESENTE show that absorption is minimal until about the 90th post implantation day and is essentially complete between 180 and 210 days.
PEDESENTE sutures are available as sterile, dyed (violet) and undyed (natural) strands in sizes USP 7/0 - USP 2 (metric sizes 0.5 - 5) in a variety of lengths, with or without various needles.
Sutures are available in one or two dozen boxes.
The product should be kept dry and clean. Store below 30ºC and keep away from direct sunlight and moisture. Do not use products after expiry (“use by”) date
PEDESENTE sutures, being absorbable, should not be used where prolonged (beyond 6 weeks) approximation of tissues under stress is required or in conjunction with prosthetic devices, for example, heart valves or synthetic grafts.
The safety of PEDESENTE sutures have not been established in contact with the central nervous system, in adult cardiac tissue or in large vessels.
Users should be familiar with surgical procedures and techniques before employing absorbable sutures for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material is used. Users should consider the in vivo performance, under ACTIONS section, when selecting a suture. The use of this suture may be inappropriate in elderly malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing.
As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation. As this is an absorbable suture material; it may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching, or distention, or which may require additional support.
Sterility is preserved only when opened under sterile conditions.
Do not re-sterilize.
Store at room temperature and avoid prolonged exposure to elevated temperatures.
Discard opened packages and unused sutures. Do not use opened or damaged products.
This device is single use. Known hazards with reuse or resterilization of opened/original packages of the device are cross contamination, infection, early degradation, trauma.
In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.
As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
Conjunctival, cuticular and vaginal epithelium sutures which remain in place longer than 10 days may cause localized irritation and should be snipped off or removed. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with the absorption process.
Under some circumstances, notably orthopedic procedures, immobilization of joint by external support may be employed at the discretion of the surgeon.
Consideration should be taken in absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.
To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.
Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.
Discard used needles in "sharps" containers.
Do not use expired products.
Adverse effects associated with the use of this device include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching or distention occur, failure to provide adequate wound support in elderly malnourished, or debilitated patients, or in patients suffering form conditions which may delay wound healing, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transitory localized irritation when conjunctival, cuticular and vaginal epithelium sutures are left in place for greater than 10 days, erythema and induration during absorption with subcuticular sutures, suture extrusion and delayed absorption in tissue with poor blood supply. Broken needles may cause complications 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.