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

NCT ID: NCT05120739

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional

Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths

Group Type EXPERIMENTAL

2% CHX cloths

Intervention Type DRUG

skin preparation in 2% CHX cloths

Control

Skin preparations (the day before and the morning of the operation) with the 4% CHX soap (standard of care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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2% CHX cloths

skin preparation in 2% CHX cloths

Intervention Type DRUG

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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38RC19.254

Identifier Type: -

Identifier Source: org_study_id

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