CATGUT
ABSORBABLE, SURGICAL SUTURES, USP/ EP/TS3497

DESCRIPTION
Surgical gut suture is an absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from submucosal fibrous layer of sheep (ovine) intestines. Surgical gut sutures are available in plain or chromic. Chromic gut is processed to provide greater resistance to absorption. Surgical gut is packaged in tubing fluid. Chromic gut is chemically treated with chromic salt solutions to provide greater resistance to absorption. Plain catgut is naturally cream coloured. Chromic catgut is coloured brown by pyrogallol. Chromic gut suture is also available in blue (Indigo) dyed. Surgical catgut is packaged in dry or in conditioning fluid. The fluid is consist of;  
             ·            Isopropyl alcohol, %93.75
·    Diethyl ethanolamine,  %1.00
·    Sodium benzoate, %0.25
·    Water, %5.00
Surgical gut suture meets all the requirements established by the United States Pharmacopoeia (U.S.P.) Of monographs and  European Pharmacopoeia (E.P.).
INDICATIONS
Surgical 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 tissues.   
ACTIONS
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 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:
-Type of suture - plain gut generally absorbs 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
This suture, being absorbable, should not be used where extended approximation of tissue is required.
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
Users should be familiar with surgical procedures and techniques involving gut suture before using surgical gut suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. User should consider the in vivo performance when selecting a suture. 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 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, surgical gut may act transiently as a foreign body.
Do not resterilize. Discard open packages and unused sutures.
Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
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 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 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 needleholders.
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.
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.
Avoid prolonged exposure to elevated temperatures.
ADVERSERE ACTIONS
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 occurs, 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, anaemia, 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, 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.
HOW SUPPLIED
Surgical gut sutures are available in U.S.P. sizes 6/0 thru 4 (metric sizes 1 - 8) in a variety of lengths with and without permanently attached needles. The suture is supplied sterile in one, two, and three dozen boxes.
STORAGE
Store below 25oC, Keep away from, sunlight.
Protect from humidity.
Do not use after expiry date.