NCT05158322

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 14, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

November 25, 2021

Last Update Submit

March 18, 2026

Conditions

Keywords

Decolonization S. Aureus

Outcome Measures

Primary Outcomes (1)

  • 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)

    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.

    6 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients who are going to be operated

You may qualify if:

  • 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.

You may not qualify if:

  • Patients scheduled for VPE less than 2 days after surgery.
  • Patients unable to give their informed consent freely. Inadequate cognitive ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Surgical Wound InfectionPatient Satisfaction

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Francisco Zamora-Carmona, Nurse

    Corporació Parc Tauli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Enfermero Práctica Avanzada

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 15, 2021

Study Start

October 14, 2021

Primary Completion

March 16, 2026

Study Completion

March 16, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations