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

Study Overview
=================
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.

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

Conditions
-----------------
Orthopedic Surgery

Intervention / Treatment
-----------------
* Drug: 2% CHX cloths


Participation Criteria
=================
Eligibility Criteria
-----------------
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,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths | Drug: 2% CHX cloths<br>* skin preparation in 2% CHX cloths<br>|
| No Intervention: Control<br>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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chlorhexidine, cloths, orthopedic surgery, preoperative bath