Suture antibatteriche: mito o realtà? Michele Zuolo U.O Chirurgia Generale Ospedale «Valli del Noce» Cles Direttore: Dott. M.

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1 Suture antibatteriche: mito o realtà? Michele Zuolo U.O Chirurgia Generale Ospedale «Valli del Noce» Cles Direttore: Dott. M. Rigamonti

2 Background Triclosan: agente antisettico (5-cloro-2-(2,4-diclorofenossi) fenolo) con azione battericida (distrugge la membrana cellulare e diverse strutture del citoplasma batterico). Gli studi in vitro hanno dimostrato che forma un alone di inibizione attorno alla sutura rivestita e che è efficace contro i patogeni responsabili della maggior parte delle SSI, Gram positivi e Gram negativi. Presente nel mercato fin dagli anni 70, nel 2002 la FDA approva la prima sutura antimicrobica rivestita con triclosan (Vicryl Plus, Ethicon, Johnson & Johnson).

3 Methods MEDLINE /PubMed Keywords: surgical site infection, antibacterial sutures, triclosan. Multi-center RCT, systematic review and meta-analysis. 9 papers + 2 guidelines Disclosure: conflict of interest My disclosure: no conflict of interest

4 13 RCTs: 3568 patients Surgery 2013

5 Surgery RCTs: 3568 patients Conclusions: «Antimicrobial suture was effective in decreasing the risk for postoperative SSIs in a broad population of patients undergoing surgery»

6 Surgical Infections RCTs: 4800 patients Conclusions: «This systematic literature review and meta-analysis [...], demostrating a highly statistically significant, lower risk of SSI [...] in incision which were closed with TCS compared to non-antimicrobial closure technology». «TCS appears to be predominant factor associated with a reduction in the incidence of SSI»

7 Gastroenterology Report RCTs: 1631 patients Conclusions: «...our conclusion [...], it should be considered cautiosly because the quality of the majority of included trials was poor». «There is still a lack of stronger evidence to support the routine use of ABS».

8 Br J Surg RCTs: 3720 patients Conclusions:

9 Lancet centres: 1185 patients who underwent elective midline abdominal laparotomy for any reason. Primary endpoint: occurrence of a superficial or deep SSI, according to the CDC criteria did not differ between the two groups. Secondary endpoint: frequency of wound dehiscence (cutaneuos and subcutaneous layer) and burst abdomen (fascial deiscence) did not differ between the two groups. Conclusions: PROUD trials showed no effect of triclosan-coated PDS Plus sutures on SSI.

10 5 RCTs: 3020 patients Lancet 2014

11 Br J Surg 2017 «The aim of this study was to find a more definitive answer to the question of efficacy of triclosan-coated sutures in the prevention of SSI». 21 RCTs: 6462 patients «Of the 21 RCTs, 15 were single-centre trials, 5 were multicentre trials and 1 abstract did not report on singlecentre or multicentre character». «6 studies had a potential conflict of interest, 4 had no potential conflict of interest and 11 had an unclear potential conflict of interest». «In a meta-analysis of all the 21 trials, SSIs were reduced significantly by the use of TCS compared with a comparable uncoated variant (p<0.001)». «Overall, the risk of bias was assessed as serious. [...] Overall, the quality of evidence was moderate».

12 Surgical Infections centres: 385 patients Conclusions: «SSI develops more often after colorectal than after other clean-contaminated operations». «There were no significant differences in SSI in the two groups». p=0.982

13 Surgical Infections centres: 281 patients Primary outcome: the rate of SSI within 30 days after surgery (superficial and deep incisional SSI). Conclusions: «No statistically significant difference in the overall rate of SSI between treated and control group. Similar results were obtained when SSI were divided between superficial and deep».

14 Surgical Infections centres: 281 patients Secondary outcome: the overall rate of incision complications. Conclusions: «The overall wound complication rate was 45.7% in the triclosan group versus 38.3% in control group. The patients treated with TCS had significantly more wound hematomas than the control group».

15 Medicine RCTs: 2168 patients Primary outcome: the rate of SSI within 30 days after surgery the overall rate was 11.7% in the triclosan group and 13.4% in control group (p=0.220). «Single-center studies were associated with a significant reduction of SSI in the TCS group (p=0.003), whereas in trials conducted in multiple centres, this protective effect was not evident (p=0.602)». Conclusions: «The results suggest that TCS do not significantly affect the rate of SSI in patients undergoing elective colorectal resection». «At the moment, there are no well-designed studies that may prove that this tecnology is a dominant strategy»

16 «...the low to moderate quality of evidence and the low quality of RCTs included in the metaanalyses».

17 Take home messages Current evidence failed to demonstrate a significant protective effect of tricolosan-coated sutures on the occurence of SSI. Abdominal wall closure with looped polydioxanone, independently of whether it is coated or uncoated, decreases the SSI rate. In the absence of clear benefit, it is not currently possible to recomend the routine use of tricolosan-impregnated sutures. Further large RCTs that take into account all risk factors and the supplementary preventive strategies are needed before introducing it in a routine clinical use.