CG-912

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>Plain, chromic, and mild chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological surgery and microsurgery.</p> <h3>Actions</h3> <p>When plain, chromic, and mild chromic gut absorbable sutures are placed in tissue, a moderate tissue inflammation occurs characteristic of foreign body response to a substance. This is followed by a gradual loss of tensile strength and suture mass, as the enzymatic process dissolves the surgical gut until it is completely absorbed. </p> <p>Many variable factors may affect the rate of absorption. Some of the major factors which may affect tensile strength loss and absorption rates are:</p> <ul> <li>Type of suture — Plain gut is expected to absorb more rapidly than chromic gut.</li> <li>Infection — Surgical gut is absorbed faster in infected tissue than in noninfected tissue.</li> <li>Tissue sites — Surgical gut will absorb more rapidly in tissue where increased levels of enzymes are present, as in secretions exhibited in the stomach, cervix, and vagina.</li> </ul> <h3>Contraindictions</h3> <ul> <li>The use of these sutures is contraindicated in patients with known sensitivities or allergies to bovine collagen or chromium, as gut is a collagen based material and chromic gut is treated with chromic salt solutions.</li> <li>This suture, being absorbable, should not be used where extended approximation of tissue is required.</li> </ul> <h3>Warnings</h3> <ul> <li>As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation.</li> <li>Do not resterilize. Sterile unless packaging has been opened or damaged. </li> <li>Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.</li> <li>Users should be familiar with surgical procedures and techniques involving gut sutures before using plain, chromic, and mild chromic gut absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.</li> <li>Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.</li> <li>The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.</li> <li>The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.</li> <li>Certain patients may be hypersensitive to bovine collagen or chromium and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation and the potential for allergic reactions including delayed anaphylactic reaction.</li> </ul> <h3>Precautions</h3> <ul> <li>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.</li> <li>Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.</li> <li>The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.</li> <li>Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon to reduce the occurrence of surface fraying and weakening of the strand.</li> <li>Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.</li> </ul>

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