Journal Summary 2

Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial Coating on Coated VICRYL^® Plus Antibacterial Suture (Coated Polyglactin 910 Suture with Triclosan)

Triclosan is a broad-spectrum antimicrobial agent that has a history of use in personal care and oral health products. In this article, Barbolt has reviewed the triclosan safety information from published studies and the triclosan Drug Master File. The acute toxicity of triclosan has been evaluated with several routes of administration, including oral (LD₅₀ values of 4,350; 3,750-5,000; and >5,000 mg/kg for mice, rats, and dogs, respectively), dermal under occlusion (LD₅₀ >9,300 mg/kg in rabbits), and subcutaneous (LD₅₀ >14,700 mg/kg for rats). Safety factors following prolonged oral and dermal exposure ranged from 1,000 to 25,000 times the no-observed-effect levels (NOEL). Long-term studies demonstrated no carcinogenic potential, genotoxicity and reproductive toxicity studies were negative, and immunotoxicity studies in guinea pigs and repeat patch tests in humans both demonstrated no evidence of skin sensitization. A number of pharmacokinetic studies have also been conducted with triclosan, indicating rapid absorption, good distribution, metabolism in the liver, excretion by the kidneys, and no indication of accumulation over time. In an attempt to develop a synthetic, absorbable suture with antimicrobial properties, triclosan has been added to the current coating of coated polyglactin 910 suture (Coated VICRYL^® Plus Antibacterial suture). Using existing data for polyglactin 910 suture and triclosan, in addition to new studies with representative dyed, coated polyglactin 910 with triclosan (as a worst case scenario), the biocompatibility of coated polyglactin 910 suture with triclosan has also been reviewed. The data indicated that coated polyglactin 910 suture with triclosan was non-cytotoxic, nonirritating, and not a chemical pyrogen. Moreover, an intramuscular implantation study demonstrated that the tissue reaction, healing response, and absorption profile were comparable with those of the traditional coated polyglactin 910 suture. The safety and biocompatibility of triclosan, together with the relatively low level required to inhibit bacterial colonization, support the use of coated polyglactin 910 suture with triclosan and indicate the potential of this suture for reducing surgical site infections.

Barbolt TA. Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial Coating on Coated VICRYL® Plus Antibacterial Suture (Coated Polyglactin 910 Suture with Triclosan). Surgical Infections. 2002;3:S45-S53.

Read full text>