Clinical trial NCT05120739: Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery
Official title: Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Keywords: chlorhexidine
cloths
orthopedic surgery
preoperative bath
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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,

Primary outcomes:
measure: Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)
timeFrame: 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 outcomes:
measure: Relative decrease in the number of bacterial colonies after 1 preoperative skin preparation
timeFrame: Between the patient's admission to the CHU GA and after 1 preoperative skin preparation (Day 0)
measure: Relative decrease in the number of bacterial colonies after 2 preoperative skin preparations
timeFrame: Between the patient's admission to the CHU GA and after 2 preoperative skin preparations (Day 1)
measure: Significant predictors of a decrease in bacterial colonization
timeFrame: 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)
measure: Percentage of skin adverse reactions
timeFrame: 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)
measure: Nursing load
timeFrame: 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)
measure: Duration of preoperative skin preparation
timeFrame: 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)
measure: Responses to a questionnaire for patients and adherence score
timeFrame: Between surgery and discharge from the hospital (Day 4)
measure: Responses to a semi-structured interview intended for healthcare professionals
timeFrame: Interview at the end of the inclusion of patients (through study completion, an average of 6 months)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu de Grenoble Alpes
Study officials:
References: