Nurse's RoleNCT05158322
Effectiveness of the Decolonization Circuit of S. Aureus, Reducing Infection in Primary Arthroplasty of the Lower Limb
An observational study of Nurse's Role and Surgical Site Infection, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Lower limb joint replacement surgery is one of the most prevalent globally. In our center, more than 400 lower limb arthroplasties (LLA) are performed annually. Developing a Surgical Site Infection (SSI) after (LLA) increases morbidity, mortality and healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse's Role, Surgical Site Infection, Patient Satisfaction
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2021to 16 Mar 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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
Study population: All the patients who are going to be operated
Who may be able to join
- Over 18 years old
- Patients who are going to undergo knee or hip replacement surgery.
- Patients with a positive result in the first nasal smear to S. aureus, and follow the decolonization protocol.
- Patients who give their informed consent to participate in the study.
Who cannot join
- Patients scheduled for VPE less than 2 days after surgery.
- Patients unable to give their informed consent freely. Inadequate cognitive ability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Staphylococcus Aureus Decolonization Circuit in Reducing Infection at the Surgical Site in Patients Scheduled for Primary Arthroplasty in the Lower Limb
Lower limb joint replacement surgery is one of the most prevalent globally. In our center, more than 400 lower limb arthroplasties (LLA) are performed annually. Developing a Surgical Site Infection (SSI) after (LLA) increases morbidity, mortality and healthcare costs. Staphylococcus aureus is the main causative agent of SSI and especially in LLA. One third of the population is a nasal carrier of Staphylococcus aureus, being a risk factor for patients who have to undergo knee replacement or hip replacement. Several studies have confirmed that the detection of S. aureus carriers and their subsequent decolonization reduces SSI rates
Read the detailed description
Implementation of a screening of all patients who have to undergo lower limb arthroplasty in our center, decolonization of patients with a positive screening result for S. aureus and subsequent follow-up.The circuit is established in the following phases:
- Preoperative Nurse Visit: Oral and written information on the study and procedure is given, the informed consent will be signed, and the sample (nasal swab) is collected from all patients scheduled for lower limb arthroplasty surgery in our center. The sample is sent to microbiology. It will be recorded in the computerized medical history.
- Control of results: If the sample has been run by rapid circuit at 24 hours or conventional at 4 days, the Consultation Nurse reviews the results of the screened patients.
- In case of negative screening, patients follow the usual clinical practice circuit.
- In case of positive screening, the patients are summoned the next day to Consultations to give and explain the decolonization treatment.
- Indication of decolonization to S. aureus: The following treatment is prescribed and facilitated in the nurse's office and will be recorded in the history:
- Intranasal mupirocin every 8h. for 5 days (in case of resistance, intranasal fusidic acid is given every 12 hours for 5 days). Treatment is always carried out 7 days before the day of admission for surgery.
- Chlorhexidine gluconate (single-dose sachets) daily shower until the day of admission for the intervention.
- Post-decolonization control S. aureus: The patient is asked about adherence to treatment and a nasal smear is performed in the Presurgical Unit. In the event that the Innervencion is before the end of the treatment. It is not deprogrammed, but the treatment will continue until it is completed. The control nasal smear, in these cases, will be collected at the first treatment in the nurse's office. The satisfa
- The patients will be followed for 6 weeks, a period in which an infection is considered an acute surgical site, it will be recorded if the infection is due to S. aureus.
- The circuit will be evaluated in relation to efficacy and impact (number of patients operated on, number of screening, number of S. aureus positives, number of decolonizations and if they have been effective, number of S. aureus infections after The proposed intervention and treatment will be compared with the infections of the same period of the year 2019.ction survey of the decolonization protocol (VAS 0-10) will be carried out.
- Conditions
- Nurse's Role, Surgical Site Infection, Patient Satisfaction
- Keywords
- Decolonization S. Aureus
- Medical subject headings
- Surgical Wound Infection, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate with a VAS scale (0-10) the satisfaction of the participant with the information on the decolonization process of S. aureus.
The participant is satisfied with the information received throughout the decolonization. to be assessed with the EVA scale (0 not at all satisfied / 10 very satisfied)
Measured: 6 weeks
Secondary outcomes (1)
The participant evaluates his social well-being on the VAS scale (0-10) based on the care received by professionals throughout the S. aureus decolonization process. The number of patients who scored 9 or 10 on the VAS scale will be assessed as satisfied.
Number of participants who perceive well-being with the VAS scale (0 very dissatisfied / 10 very satisfied) linked to the quality of care throughout the decolonization process.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start14 Oct 2021
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Zamora Carmona, Corporacion Parc Tauli
- Investigators
- Francisco Zamora-Carmona, Nurse, Principal investigator, Corporació Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158322
- Sponsor's protocol ID
- DESCO-2021
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Staphylococcus Aureus Decolonization Circuit in Reducing Infection at the Surgical Site in Patients Scheduled for Primary Arthroplasty in the Lower Limb
- ClinicalTrials.gov ID
- NCT05158322
- Acronym / sponsor ID
- DESCO-2021
- Conditions
- Nurse's Role, Surgical Site Infection, Patient Satisfaction
- Keywords
- Decolonization S. Aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 15 Dec 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.
Lower limb joint replacement surgery is one of the most prevalent globally. In our center, more than 400 lower limb arthroplasties (LLA) are performed annually. Developing a Surgical Site Infection (SSI) after (LLA) increases morbidity, mortality and healthcare costs. Staphylococcus aureus is the main causative agent of SSI and especially in LLA. One third of the population is a nasal carrier of Staphylococcus aureus, being a risk factor for patients who have to undergo knee replacement or hip replacement. Several studies have confirmed that the detection of S. aureus carriers and their subsequent decolonization reduces SSI rates
Detailed description
Implementation of a screening of all patients who have to undergo lower limb arthroplasty in our center, decolonization of patients with a positive screening result for S. aureus and subsequent follow-up.The circuit is established in the following phases:
- Preoperative Nurse Visit: Oral and written information on the study and procedure is given, the informed consent will be signed, and the sample (nasal swab) is collected from all patients scheduled for lower limb arthroplasty surgery in our center. The sample is sent to microbiology. It will be recorded in the computerized medical history.
- Control of results: If the sample has been run by rapid circuit at 24 hours or conventional at 4 days, the Consultation Nurse reviews the results of the screened patients.
- In case of negative screening, patients follow the usual clinical practice circuit.
- In case of positive screening, the patients are summoned the next day to Consultations to give and explain the decolonization treatment.
- Indication of decolonization to S. aureus: The following treatment is prescribed and facilitated in the nurse's office and will be recorded in the history:
- Intranasal mupirocin every 8h. for 5 days (in case of resistance, intranasal fusidic acid is given every 12 hours for 5 days). Treatment is always carried out 7 days before the day of admission for surgery.
- Chlorhexidine gluconate (single-dose sachets) daily shower until the day of admission for the intervention.
- Post-decolonization control S. aureus: The patient is asked about adherence to treatment and a nasal smear is performed in the Presurgical Unit. In the event that the Innervencion is before the end of the treatment. It is not deprogrammed, but the treatment will continue until it is completed. The control nasal smear, in these cases, will be collected at the first treatment in the nurse's office. The satisfa
- The patients will be followed for 6 weeks, a period in which an infection is considered an acute surgical site, it will be recorded if the infection is due to S. aureus.
- The circuit will be evaluated in relation to efficacy and impact (number of patients operated on, number of screening, number of S. aureus positives, number of decolonizations and if they have been effective, number of S. aureus infections after The proposed intervention and treatment will be compared with the infections of the same period of the year 2019.ction survey of the decolonization protocol (VAS 0-10) will be carried out.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who are going to be operated
Key inclusion criteria (4 listed)
- Over 18 years old
- Patients who are going to undergo knee or hip replacement surgery.
- Patients with a positive result in the first nasal smear to S. aureus, and follow the decolonization protocol.
- Patients who give their informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Patients scheduled for VPE less than 2 days after surgery.
- Patients unable to give their informed consent freely. Inadequate cognitive ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate with a VAS scale (0-10) the satisfaction of the participant with the information on the decolonization process of S. aureus.
Time frame: 6 weeks
The participant is satisfied with the information received throughout the decolonization. to be assessed with the EVA scale (0 not at all satisfied / 10 very satisfied)
1 secondary outcome
The participant evaluates his social well-being on the VAS scale (0-10) based on the care received by professionals throughout the S. aureus decolonization process. The number of patients who scored 9 or 10 on the VAS scale will be assessed as satisfied.
Time frame: 6 weeks
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 20 Mar 2026.
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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.
Francisco Zamora-Carmona, Nurse principal investigator
Corporació Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse's Role and Surgical Site Infection, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 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 20 Mar 2026. 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 Spain. 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?
Evaluate with a VAS scale (0-10) the satisfaction of the participant with the information on the decolonization process of S. aureus. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.