ANTIBACTERIAL SUTURES Katsan Katgüt San. Tic. A.Ş 1571 sokak No:22 Çınarlı/İZMİR- TÜRKİYE Tel: +90(232)4861185 Fax: +90(232)4863379 email: info@katsanas.com www.katsanas.com TRAINING PRESENTATION NO 5: EG5/REV00/130616

Antibacterial absorbable surgical sutures; ALCASORB® PLUS, Antibacterial polyglycolic acid (PGA) ALCALACTINE® PLUS, Antibacterial polyglycolic acid (%90)-co-lactic acid(%10) (PGLA) ALCALACTONE® PLUS , Antibacterial polyglycolic acid (%75)-co-caprolactone (%25) (PGCL) ALCADINONE® PLUS , Antibacterial polydioxanone(PDO)  Katsan Antibacterial sutures contain “Chlorhexidine” as antibacterial agent.

SURGICAL SITE INFECTION Surgical site infections are really important and serious issue for the surgery in terms of mortality, morbidity, and increasing hospitalization duration and costs. Following surgical intervention, observed (within 30 days if implant isn’t used ,within one year if implant is used) infections related with surgical incision and opened or manipulated surgical site are named as surgical site infection (SSI). Suture materials are claimed as one of the risk factors that provides a basis for the growth of infection and belongs to surgical operation.

CHLORHEXIDINE 1950 – Exploration 1954 – On the market as disinfectant and topical antiseptic in England. 1970’ler –Shown that hand washing with chlorhexidine decreases ~ 90% of the skin flora. 1976 – Dental plaque inhibition ability is shown. 1981 – First urological lubricant with chlorhexidine 1988– 2% chlorhexidine and alcohol combination for skin preparation firstly put onto the market in USA. 1992 –chlorhexidine based catheter is available firstly (chlorhexidine and silver sulfadiazine impregnated) . 1993 – First chlorhexidine impregnated sponge medical dressing is on the market. 2005 – First cloth with chlorhexidine for bath is on the market. 2006 – First FDA approval of 3.15% chlorhexidine and alcohol combination for skin preparation. 2010 – First chlorhexidine impregnated cap is on the market. 2010 – First chlorhexidine based peripheral placed central catheter as antimicrobial is on the market 2012 – Chlorhexidine based peripheral placed central catheter with antimicrobial indication is available on the market.

CHLORHEXIDINE Broad-spectrum Binds to skin proteins strongly Antimicrobial activity continues 48 hours on the skin Activity on the skin with 3.15% concentration continues 7 days Low toxicity Activity is dependent to pH and decreases in the presence of organic material. Commonly used in the form of water soluble gluconat with 0.5-4% concentration.

MECHANISM OF ACTION OF CHLORHEXIDINE After entering the inside of the cell by passive diffusion across the cell wall or cell membrane; cytoplasm or internal membrane damage in bacteria, plasma membrane damage in fungi, RESULT: Leakage of the cell components. In high concentrations, coagulation in cytoplasm components and inhibition of membrane- dependent ATP-ase.

EFFECT SPECTRUM OF CHLORHEXIDINE Best activity against gram-positive bacteria. Gram-negative bacteria, Anaerobes, Fungi, Some enveloped viruses, Mycobacteria are generally highly resistant, Absence of activity against spores.

CLINICAL CHLORHEXIDINE AND GENERAL USAGE FIELDS Hand hygiene Skin disinfection before operation Insertion of the intravenous catheter Intravenous catheter care Bath of intensive care patient MRSA decolonization Prevention of intravenous catheter infections Impregnated dressings for catheter site.

CLINICAL CHLORHEXIDINE AND GENERAL USAGE FIELDS Eye lotions Disinfection of contact lenses Antiseptic creams, mouthwashes, Dental gels Sterilization of catheters in urology Irrigation of bladder, Medical wound bandages, powder, sprays and creams Prevention of dental plaque formation in oral cavity, healing of gingivitis and periodontitis Periodontal treatment and prevention of decay formation Infections which may occur after surgical operations, Defined as an effective antimicrobial agent used for general oral infections.

TRICLOSAN In contemporary biomedical era which technology has intertwined with medicine and all medical fields, developments in rapidly growing and changing molecular biology and related technologies, has provided manufacturing of suture materials with the desired properties. Modern suture materials are composed of pretty well refined materials and prepared by passing the rigorous tests. Nowadays, reformed suture materials are manufactured in such a way that exhibits minimal absorption time changes, better tensile strength, less tissue reaction and prevention of infections. Triclosan coated antibacterial suture materials have started to be manufactured and used for surgical intervention since 2003.

TRICLOSAN Triclosan has been used as an antibacterial agent more than 40 years. It’s a non- ionic colorless material developed by Ciba laboratories in 1960s. Chemical name; 2,4,4-trichloro-2-hydroxydiphenyl ether. Triclosan has commercial names such as Irgasan DP 300, Irgasan PG60, Irgacare MP, Irgacare CF100, Irgacide LP10, Cloxifenolum, Irgagard B1000, Lexol 300, Ster- Zac.

TRICLOSAN In 1972, Triclosan has been used firstly inside of the soaps used for washing hands for the purpose of destruction of bacteria found in the skin and surfaces and prevention of bacterial growth. Later on, also used in the deodorants, cosmetics, cleaning lotions, plastics, toothpastes, kitchen wares, garbage bags and textile products. 0.2-2% concentrations of the triclosan have antimicrobial effect. In 1994, triclosan was classified as Category IIISE active agent tentatively up to 1% by FDA TFM (Datas are insufficient to classify as a safe and effective for antiseptic hand washing). FDA has still continued to evaluate this agent.

TRICLOSAN It’s reported that triclosan has especially effective on gram-positive bacteria, and less effective on some of the gram-negative bacteria, fungi and spores. Usage of this material in low concentrations (Minimum inhibitor concentrations: 0.1 to 10 microgram/m) indicates bacteriostatic effect, while usage in high concentrations (25-500 microgram/m) indicates bactericidal effect. But it’s known that common usage causes to resistance formation of the microorganisms. However, due to the absence of a strong activity of Triclosan against Gram- negative bacilli, some of the reports indicates contamination of triclosan.

TRICLOSAN The EU Scientific Committee (SSCB) has prepared two important reports about damages and cross resistance response of triclosan. Two parliamentary question were given to TBMM Ministry of Health for answering regarding products containing triclosan. Sweden gives right to prohibit sutures containing triclosan to Country Council of Jämtland . http://www.chemsec.org/en/news/news-2010/october- december/633-court-decision-allows-swedish-county-to-maintain- triclosan-free-purchasing-policy

TRICLOSAN From its webpage, manufacturer (Only Ethicon-J&J manufactures sutures with triclosan all over the world) company declares discontinuation the production of triclosan containing personal care and cosmetic products until the end of the 2015 November. Personal care and cosmetic products are products for external use. Surgical sutures are used inside of the body. So, discontinuation of the production of triclosan coated (antibacterial) surgical sutures by manufacturer will be inevitable.

THANKS…