Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery (POL)

Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Drug: 2% CHX cloths

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38700
    • CHU de Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths	Drug: 2% CHX cloths; skin preparation in 2% CHX cloths
No Intervention: Control; Skin preparations (the day before and the morning of the operation) with the 4% CHX soap (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative decrease in the number of bacterial colonies after 1 preoperative skin preparation	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)	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 after 2 preoperative skin preparations	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)	Between the patient's admission to the CHU GA and after 2 preoperative skin preparations (Day 1)
Significant predictors of a decrease in bacterial colonization	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	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	Percentage of skin adverse reactions after 2 preoperative skin preparations in the 2% CHX cloths group versus the 4% CHX soap group.	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	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	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	Duration of preoperative skin preparation in minutes in the 2% CHX cloths group versus 4% CHX soap group.	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)
Responses to a questionnaire for patients and adherence score	Responses to a questionnaire for patients and adherence score in the 2% CHX cloths group versus the 4% CHX soap group.	Between surgery and discharge from the hospital (Day 4)
Responses to a semi-structured interview intended for healthcare professionals	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.	Interview at the end of the inclusion of patients (through study completion, an average of 6 months)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: chlorhexidine; cloths; orthopedic surgery; preoperative bath
• Other Study ID Numbers: 38RC19.254

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No