Evaluation of microbiological efficacy of 2% chlorhexidine gluconate cloths versus 4% chlorhexidine gluconate soap for preoperative preparation/shower in total joint arthroplasty: a single-centre randomised controlled trial

评估2%葡萄糖酸氯己定湿巾与4%葡萄糖酸氯己定皂在全关节置换术术前准备/淋浴中的微生物学功效:一项单中心随机对照试验

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Abstract

BACKGROUND: Preventing surgical site infections (SSI) is crucial and, among preventive measures, preoperative shower is recommended to decrease skin bacterial colonisation. However, there is no recommendation on the use of Chlorhexidine gluconate (CHG) impregnated cloths in this indication. The objective was to assess the microbiological efficacy of 2% CHG cloths for preoperative preparation/shower. METHODS: In this single-centre parallel group trial, patients were randomised (1:1) to receive either 2% CHG cloths (intervention) or 4% CHG soap (standard-of-care) the night before and the morning of the surgery. Samples were taken to assess skin bacterial colonisation in colony forming units (CFU)/cm² at the surgical site: before (T1) and after (T2) the first preparation/shower, before (T3) and after (T4) the second preparation/shower, and before antisepsis in the operating theatre (T5). Side effects were evaluated; patients and healthcare workers (HCW) answered a survey to assess adherence. RESULTS: From 07/07/2022 to 25/05/2023, 64 patients were included; 32 in each group. There was no significant difference in the median reduction of CFU/cm² between T1 and T5: median reduction of 100% (IQR:100-100) in both groups. There was a greater reduction in the intervention group after the 1st preparation/shower (T1-T2): 100% (IQR:100-100) versus 99.9% (IQR:99.3-100) in the standard-of-care group (p = 0.0001). Side effects were slightly more frequent in the intervention group, but all of them were mild. Satisfaction of patients and HCW was globally high despite ecological concerns. CONCLUSIONS: The use of CHG cloths for preoperative preparation/shower seems to be a good alternative. These results must be confirmed by assessing the impact on SSI. TRIAL REGISTRATION: The trial was approved by the French Ethics Committee (ID-RCB: 2021-A00455-36) and it was registered on ClinicalTrials.gov (NCT05120739).

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