RecruitingNCT07354893

Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

Evaluation of an Educational Intervention on Knowledge and Awareness of Infectious Risk in Splenectomized Patients and on Their Satisfaction With Vaccination Management in an Intra-hospital Outpatient Setting.


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

100 participants

Start Date

Jan 13, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The absence or dysfunction of the spleen is associated with a substantially increased risk of invasive infections that may rapidly progress to fulminant sepsis, including overwhelming post-splenectomy infection (OPSI), a medical emergency with high mortality. Although the risk is greatest in the first two years after splenectomy, it persists lifelong. Preventing infections in patients with anatomical or functional asplenia requires an integrated strategy that includes patient education, early recognition of symptoms, behavioral measures, antibiotic prophylaxis when indicated, and vaccination. Post-splenectomy immunization has been shown to reduce OPSI incidence. Regional and international guidelines recommend vaccination against pneumococcus, Haemophilus influenzae type b, meningococcus (B and ACWY), herpes zoster, diphtheria-tetanus-pertussis, measles-mumps-rubella-varicella, and annual influenza. However, adherence to these recommendations is frequently suboptimal, often due to limited awareness among patients and healthcare professionals. This study involves the intra-hospital vaccination team providing structured vaccination consultations to splenectomized patients hospitalized at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. During ward consultations, patients receive an educational intervention on asplenia-related infectious risks and preventive measures, supported by standardized informational materials. Effectiveness is evaluated using a pre-post questionnaire assessing knowledge and awareness. Patients completing the vaccination pathway at the outpatient clinic also complete a questionnaire assessing their experience with vaccination management in an intra-hospital setting.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adult patients (≥18 years old)
  • Patients splenectomized at FPG for whom a vaccination consultation is requested during hospitalization
  • Patients who provide signed informed consent to participate in the study and for the processing of personal data for research purposes

Exclusion Criteria3

  • Minor patients
  • Lack of signed informed consent for participation in the study and for the processing of personal data for research purposes
  • Patients splenectomized at other healthcare facilities

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHEREducational intervention for asplenic patients

an educational intervention aimed at informing patients about the condition of asplenia, the associated infectious risks, and the main preventive measures, with particular emphasis on vaccination prophylaxis. To support the intervention, educational materials will be distributed, including an informational brochure and the "Recommended Vaccinations for Asplenic Patients" schedule.


Locations(2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07354893


Related Trials