Orthopedic SurgeryPOLNCT05120739
Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery
A study testing 2% CHX cloths in people with Orthopedic Surgery, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- 2% CHX cloths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients,
- undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
- admitted the day before the operation
- and having given their written consent.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps
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.
- Conditions
- Orthopedic Surgery
- Being tested
- 2% CHX cloths
- Keywords
- chlorhexidine, cloths, orthopedic surgery, preoperative bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% CHX clothsDrug
skin preparation in 2% CHX cloths
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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
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)
Measured: 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
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
Measured: 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
Percentage of skin adverse reactions after 2 preoperative skin preparations in the 2% CHX cloths group versus the 4% CHX soap group.
Measured: 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
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
Measured: 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
Duration of preoperative skin preparation in minutes in the 2% CHX cloths group versus 4% CHX soap group.
Measured: 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)
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.
Measured: Between surgery and discharge from the hospital (Day 4)
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.
Measured: Interview at the end of the inclusion of patients (through study completion, an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start15 Nov 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120739
- Sponsor's protocol ID
- 38RC19.254
- Acronym
- POL
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41291848
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps
- ClinicalTrials.gov ID
- NCT05120739
- Acronym / sponsor ID
- POL / 38RC19.254
- Conditions
- Orthopedic Surgery
- Keywords
- chlorhexidine, cloths, orthopedic surgery, preoperative bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: 2% CHX clothsSkin preparations (the day before and the morning of the operation) with the 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients,
- undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
- admitted the day before the operation
- and having given their written consent.
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% CHX clothsskin preparation in 2% CHX cloths | Drug | Interventional |
Primary outcome
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.
8 secondary outcomes
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 after 2 preoperative skin preparations
Time frame: 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
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
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
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
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)
Responses to a questionnaire for patients and adherence score
Time frame: Between surgery and discharge from the hospital (Day 4)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 41291848Gallouche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% CHX cloths in people with Orthopedic Surgery, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.