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Description

Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines. The chromic gut contains a chromic salt solution to delay absorption. Surgical gut suture meets all requirements established by the United States Pharmacopeia (U.S.P.) for absorbable surgical sutures.

Indications

Surgical gut (Plain and Chromic) 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 Surgical 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:

  1. Type of Suture – PLAIN gut generally absorbs more rapidly than CHROMIC gut.                   

  2. Infection – Surgical gut is absorbed more rapidly in infected tissue than in non-infected tissue. tissue.              

  3. Tissue Sites  Surgical gut will absorb more rapidly in tissue where increased levels of proteolytic enzymes are present, as in the secretions exhibited in 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 to be used where extended approximation of tissue is required. Users should be familiar with surgical procedures and techniques involving absorbable sutures before using surgical 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 this suture may be inappropriate in patients suffering from conditions which may delay wound healing. As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites undergoing expansion, stretching, or distension, or which may require additional support. Certain patients may be hypersensitive to collagen or chromium and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus inflammation.

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 techniques 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. 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 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

Surgical Gut Suture (Plain or Chromic) is available in sizes 8-0 through 5 (metric sized 0.4-7). The suture is supplied sterile in “pre-cut” lengths or non-needled or attached to various needle types in one dozen boxes. Suture can be supplied with packing fluid 90% Isopropyl Alcohol, 0,5% Sodium Benzoate, 0,5% Diethylethanolamine and water q.s. ad 100%, or without.