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
• Status: Completed
• 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
• 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
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient undergoing surgery

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

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)