| SURGEASY CHROMIC GUT |
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DESCRIPTION:
GUT SUTURE is absorbable sterile suture composed of purified connective tissue (mostly collagen) derived fiom either the serosal layer of beef (bovine) intestines. They are packaged in a solution of 90% Isopropyl Alcohol, 0.5% Sodium Benzoate, 0.5% Diethylethanolamine, q.s. and 100% Pure Distilled Water. Chromic gut is treated with chromic salt solution.
GUT SUTURE meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture.
INDICATIONS:
GUT SUTURE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
ACTIONS:
When GUT SUTURE is placed in tissue, a moderate tissue inflammation occurs characteristic of foreign body response to a substance. This is followed by a loss of tensile strength and suture mass, aS the proteolytic enzymatic digestive process dissolves the surgical gut. This process continues until the suture is completely absorbed. Many variable factors may affect the rate of absorption. Some of the major factors, which can affect tensile strength loss and absorption rates are:
- Type of suture-Plain gut generally is expected to absorb more rapidly than chromic gut.
- Infection-Surgical gut is absorbed more rapidly in infected tissue than in non-infected tissue.
- Tissue Sites-Surgical gut will absorb more rapidly in tissue where increased levels of proteolytic enzymes are present, as in the secretions exhibited in the stomach, cervix and vagina.
Contraindications:
The use of this suture is contraindicated in patients with known sensitivities or allergies to collagen or chromium, as gut is a collagen based material, and chromic gut is treated with chromic salt solutions.
Warnings:
Do not resterilize. Discard open, unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures.
As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.
This suture, being absorbable, should not be used where extended approximation of tissue is required.
Users should be familiar with surgical procedures and techniques involving gut suture before using GUT SUTURE for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.
The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites, which may undergo expansion, stretching, or distention or which may require additional support.
Certain patients may be hypersensitive to collagen or chromium and might exhibit an immunilogical reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation.
Precautions:
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.
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 monoflaments.
The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the stand.
Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.
Adverse Reactions:
Adverse effects associated with the use of this device include: wound dehiscence, variable rates of absorption over time (depending on the type of suture used, the presence of infection and the tissue site), failure to provide adequate wound support in closure of sites where expansion, stretching or distension occur, etc., unless additional support is supplied through the use of nonabsorbable suture material, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from cancer, anemia, obesity,
diabetes, infection or other conditions which may delay wound healing, allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation, infected wounds, moderate tissue inflammatory response characteristic of foreign body response, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation.
How Supplied:
GUT SUTURE sutures are available sterile, in U.S.P. sizes 6-0 through 2 (metric sizes 1.0 - 6.0) in chromic and plain gut, in a variety of lengths, with or without permanently attached needles. GUT SUTURE sutures are available in one and three dozen boxes.
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