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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120739
Other study ID # 38RC19.254
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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)
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