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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
64
skin preparation in 2% CHX cloths
Chu de Grenoble Alpes
Grenoble, France
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.
Time frame: 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 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Interview at the end of the inclusion of patients (through study completion, an average of 6 months)
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