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

Orthopedic Surgery Clinical Trial

— POL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120739
• Other study ID #: 38RC19.254
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Orthopedic Surgery

Intervention

Drug:
• 2% CHX cloths
skin preparation in 2% CHX cloths

Locations

Country	Name	City	State
France	Chu de Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)