DESCRIPTION

Plain Gut is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Plain Guts are sterile and elicit only a slight to minimal tissue reaction during absorption. Plain Guts differ from U.S.P.minimum strength requirements by less than 30%.

INDICATIONS

Plain Guts are intended for dermal (skin) suturing only. They should beutilized only for external knot tying procedures.

ACTIONS

The results of implantation studies of Plain Guts in the skin of animalsindicate that nearly all of its original strength is lost within approximately seven (7) days ofimplantation. When surgical gut suture is placed in tissue, a moderate tissue inflammation occurs which is characteristic of foreign body response to a substance. This is followed by a loss of tensile strength and a loss of 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. 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 the stomach, cervix and vagina.Data obtained from implantation studies in rats show that the absorption of these sutures is essentially complete by the twenty-first (21st) to forty-second (42nd) post implantation day.

CONTRAINDICATIONS

This suture, being absorbable, should not be used where extended approximation of tissue is required. These sutures have been designed to absorb at a rapid rate and must be used on dermal tissue only. These sutures should never be used on internal tissue. The use of this suture is contraindicated in patients with known sensitivities or allergies to collagen, as gut is a collagen based material.

WARNINGS

Users should be familiar with surgical procedures and techniques involving gut suture before using Plain Gut for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance when selecting a suture for use in patients. 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 this is an absorbable material, 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. 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 an absorbable suture,fast absorbing surgical gut may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Do not resterilize.Discard open packages and unused sutures. Store at room temperature. Certain patients may be hypersensitive to collagen and might exhibit an immunological 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. Surgical gut sutures require the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon. The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand. Avoid prolonged exposure to elevated temperatures. 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.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehiscence, variable rates of absorption over time (depending on such factors as 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 which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation, infection, 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 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 bloodborne pathogens.

HOW SUPPLIED

Plain Guts are available from sizes 5-0 (metric size 1.5) to 4#(metric size 8) with needles attached in one, two and three dozen boxes.

Figures In U.S.P Standard:

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