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NCT05788575 Clinical Trial

Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy

Surgical Site Infection Clinical Trial

Official title:
Study of the Incidence of Surgical Site Infections (SSI) in a Large Teaching Hospital in Rome, Italy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05788575
Other study ID # 1956
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date November 15, 2022

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. All patients undergoing surgery during this period were enrolled in the study. The data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which: - 5 months of continuous survey of hospitalized patients - 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material Surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days. For each surgery, information was recorded such as the type of surgery, duration, ASA score, prophylaxis.

Recruitment information / eligibility
Status Completed
Enrollment 5424
Est. completion date November 15, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patient undergoing surgery Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery
any surgery that an inpatient has undergone

Locations
Country Name City State
Italy Fondazione Policlinico Universitario "A. Gemelli" IRCCS Rome RM

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of surgical site infection 30 days or 90 days (prosthesis)
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