Clinical trial

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

NCT05120739

Name

38RC19.254

Description

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.

Trial arms

Trial start

2021-11-15

Estimated PCD

2023-05-30

Trial end

2023-05-30

Status

Completed

Treatment

2% CHX cloths

skin preparation in 2% CHX cloths

Arms:

Interventional

Size

Primary endpoint

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

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)

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,

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

Updated at

2024-01-19

1 organization

1 product

1 indication

Organization

University Hospital of Grenoble

Product

2% CHX cloths

Indication

orthopedic surgery