Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery

Not Applicable

Completed

• Conditions: Orthopedic Surgery
• Interventions: Drug: 2% CHX cloths

• Registration Number: NCT05120739
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-03
• Study Start: 2021-11-15
• Study First Posted: 2021-11-15
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• adult patients,
• undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
• admitted the day before the operation
• and having given their written consent.

Exclusion Criteria

• presence of a documented infection at the time of the intervention,
• presence of skin wounds,
• presence of antibiotic treatment within 15 days before the operation
• intolerance to CHX,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	2% CHX cloths	Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths

Primary Outcome Measures

Name	Time	Method
Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)	Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)	Relative decrease in the number of bacterial colonies measured between the patient's admission to the Grenoble Alps University Hospital (CHU GA) (T0) and after 2 preoperative skin preparations (the day before and the morning of the operation), and just before the antiseptic preparation of the operating site at the surgical room (T1) in the 2% CHX cloths group versus the 4% CHX soap group.

Secondary Outcome Measures

Name	Time	Method
Relative decrease in the number of bacterial colonies after 1 preoperative skin preparation	Between the patient's admission to the CHU GA and after 1 preoperative skin preparation (Day 0)	Relative decrease in the number of bacterial colonies measured between the patient's admission to the CHU GA (T0) and after 1 preoperative skin preparation (the day before the evening of the operation)
Relative decrease in the number of bacterial colonies after 2 preoperative skin preparations	Between the patient's admission to the CHU GA and after 2 preoperative skin preparations (Day 1)	Relative decrease in the number of bacterial colonies measured between the patient's admission to the CHU GA (T0) and after 2 preoperative skin preparations (the night before and the morning of the operation)
Nursing load	Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)	Nursing load in the 2% CHX cloths group versus 4% CHX soap group according to the Soins Infirmiers Individualisés à la Personne Soignée (SIIPS) scale
Significant predictors of a decrease in bacterial colonization	Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)	Significant predictors of a decrease in bacterial colonization among the sex, age of the patients, their co-morbidities, the use of cloths and the time between the last preoperative skin preparation and the skin sample in the operating room
Percentage of skin adverse reactions	Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)	Percentage of skin adverse reactions after 2 preoperative skin preparations in the 2% CHX cloths group versus the 4% CHX soap group.
Duration of preoperative skin preparation	Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)	Duration of preoperative skin preparation in minutes in the 2% CHX cloths group versus 4% CHX soap group.
Responses to a questionnaire for patients and adherence score	Between surgery and discharge from the hospital (Day 4)	Responses to a questionnaire for patients and adherence score in the 2% CHX cloths group versus the 4% CHX soap group.
Responses to a semi-structured interview intended for healthcare professionals	Interview at the end of the inclusion of patients (through study completion, an average of 6 months)	Responses to a semi-structured interview intended for healthcare professionals who cared for patients randomized to the 2% CHX cloths group versus the 4% CHX soap group.

Trial Locations

Locations (1)

Chu de Grenoble Alpes; 🇫🇷 Grenoble, France