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Completed

NCT Number: NCT05120739

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

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.

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Key information

Conditions

Orthopedic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Grenoble Alpes

Grenoble, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

2% CHX cloths

Drug

skin preparation in 2% CHX cloths

Primary outcomes

  1. Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)

    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 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.

Secondary outcomes

  1. Relative decrease in the number of bacterial colonies after 1 preoperative skin preparation

    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 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)

  2. Relative decrease in the number of bacterial colonies after 2 preoperative skin preparations

    Time frame: Between the patient's admission to the CHU GA and after 2 preoperative skin preparations (Day 1)

    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)

  3. Significant predictors of a decrease in bacterial colonization

    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)

    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

  4. Percentage of skin adverse reactions

    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 after 2 preoperative skin preparations in the 2% CHX cloths group versus the 4% CHX soap group.

  5. Nursing load

    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 in the 2% CHX cloths group versus 4% CHX soap group according to the Soins Infirmiers Individualisés à la Personne Soignée (SIIPS) scale

  6. Duration of preoperative skin preparation

    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 in minutes in the 2% CHX cloths group versus 4% CHX soap group.

  7. Responses to a questionnaire for patients and adherence score

    Time frame: Between surgery and discharge from the hospital (Day 4)

    Responses to a questionnaire for patients and adherence score in the 2% CHX cloths group versus the 4% CHX soap group.

  8. Responses to a semi-structured interview intended for healthcare professionals

    Time frame: Interview at the end of the inclusion of patients (through study completion, an average of 6 months)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: POL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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