RASTORO (Sterilized Absorbable Polyglycolic Acid Sutures)
RASTORO sutures are synthetic, absorbable, sterile surgical sutures are synthetic, absorbable, sterile surgical sutures composed of Polyglycolic Acid (PGA). The empirical formula is (C2H2O2)n. RASTORO sutures are available undyed and dyed violet with D&C violet No.2 (colour index number 60725). RASTORO sutures are available as braided strands in EP sizes 0.4-6 (USP sizes 8-0 through 3 or 4), in a variety of lengths, with and without stainless steel needles of varying types and sizes. Braided sutures are uniformly coated with polycaprolactone and calcium stearate.
RASTORO sutures are also available as monofilament in EP sizes 0.2-0.3 (USP size 10-0 through 9-0), in a variety of lengths, with and without stainless steel needles of varying types and sizes. Monofilament sutures are uncoated.
RASTORO sutures complies with the requirements of the European Pharmacopoeia and for “sutures, sterile absorbable braided” and the requirements of United States Pharmacopoeia for “absorbable surgical suture”.
RASTORO sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery.
RASTORO sutures should be selected and implanted depending on patient condition, surgical experience, surgical technique and wound size.
RASTORO sutures elicits are minimal initial inflammatory reaction in tissues and are eventually replaced with an in-growth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of suture occurs by means of hydrolysis, where the polymer degrades to glyvolic which are subsequently absorbed and eliminated by the body. Absorption begins as a loss tensile of strength followed by loss of mass. Implantation studies in rats show the following profile
|DAYS implantation||Approximately % original strength remaining|
Absorption of RASTORO sutures is essentially complete between 60 and 90 days.
This suture, being absorbable should not be used where extended approximation of tissues under stress is required. The safety and effectiveness of RASTORO sutures in cardiovascular tissue and neurological tissue have not been established.
Warnings/precautions and interactions
- Do not use if package is opened or damaged. Discard opened unused sutures.
- Do not use after exp. Date
- Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing RASTORO suture for wound closure, as risk of wound dehiscence, may vary with the site of application and the suture material used. Surgeons should consider the in vivo performance (described in PERFORMANCE section) when selecting a suture.
- As with any foreign body, prolonged contact of any suture with salt solution, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture, it may act transiently as a foreign body.
- Acceptable surgical practices should be followed for the management of contaminated or infected wounds.
- As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by surgeon in the closure of the sites which may undergo expansion, stretching or distension, or which may require additional support.
- Skin structures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.
- Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.
- Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extension and delayed absorption may occur.
- Subcuticular sutures should be places as deeply as possible to minimize the erythema and induration normally associated with the absorption process.
- This suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing
- When handling this or any other suture, care should be taken to avoid damage. Avoid crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders.
- Care should be taken to avoid damage when handling surgical needles. Grasp the needle in an area one-third (1/3) to one half (1/2) of the distance from the attachment end to the point. Grasping in the 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 needles may cause them to lose strength and be less resistant to bending and breaking. Broken needles may result in extended or additional surgeries or residual foreign bodies.
- 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 additional throws may be particularly appropriate when knotting any monofilament suture.
- Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury, inadvertent needle sticks with contaminated surgical needles may result in the transmission of blood borne pathogens.
- Discard used needles in “sharps” container.
- Dispose of material in accordance with all the state, local and hospital regulations. Responsibility for proper waste disposal is with the owner of the waste.
- Do not re-use: infection hazard for patients and/or users and impairment of products functionality due to re-use. Risk of injury, illness or death due to contamination and/or impaired functionality of the product.
Adverse effects associated with the use of devices 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.