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Description

Silk surgical suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx Mory (B. Mori) of the family Bombycidae. Suture characteristics include; braided wax (refined Paraffin, N.F. or Microcrystalline Wax N.F.) coated black (Hematein dyed) or white (undyed) and twisted uncoated white virgin (undyed), or twisted uncoated white (undyed). Silk surgical suture meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.

Indications

Silk surgical suture is indicated for use in general, soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

Actions

Silk surgical suture elicits minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While Silk suture is not absorbed, progressive degradation of the proteinaceous silk fiber in vivo may result in gradual loss of the suture’s tensile strength over time.

Contraindications

The use of this suture is contraindicated in patients with known sensitivities or allergies to silk. Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, Silk Suture should not be used where permanent retention of tensile strength is required.

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. Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Silk surgical sutures 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.

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.

Adverse Reactions

Adverse effects associated with the use of this device include wound dehiscence, gradual loss of all tensile strength over time, allergic response in patients that are known to be sensitive to silk, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced bacterial infectivity, acute inflammatory tissue reaction, and pain, edema, and erythema at the wound site.

How Supplied

Silk Surgical Suture is available in U.S.P. sizes 9-0 through 5 (metric sized 0.3-7). The suture is supplied sterile in pre-cut lengths or ligation reels; both non-needled and affixed to various needle types in one dozen boxes.

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