NCT05120739

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

October 26, 2021

Last Update Submit

January 18, 2024

Conditions

Orthopedic Surgery

Keywords

chlorhexidineclothsorthopedic surgerypreoperative bath

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

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

    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

    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

    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

    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

    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)

  • +3 more secondary outcomes

Study Arms (2)

Interventional

EXPERIMENTAL

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

Drug: 2% CHX cloths

Control

NO INTERVENTION

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

Interventions

2% CHX clothsDRUG

skin preparation in 2% CHX cloths

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients,
  • undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
  • admitted the day before the operation
  • and having given their written consent.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Grenoble Alpes

Grenoble, 38700, France

Location

Related Publications (1)

  • Gallouche M, Rubens-Duval B, Boisset S, Margotton M, Caspar Y, Le Marechal M, Bosson JL, Astagneau P, Gauchet A, Landelle C. Evaluation of microbiological efficacy of 2% chlorhexidine gluconate cloths versus 4% chlorhexidine gluconate soap for preoperative preparation/shower in total joint arthroplasty: a single-centre randomised controlled trial. Antimicrob Resist Infect Control. 2025 Nov 25;14(1):143. doi: 10.1186/s13756-025-01661-z.

    PMID: 41291848DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 15, 2021

Study Start

November 15, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

FR(1)