Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT05788575
Collaborator
(none)
5,424
1
52.5
103.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
5424 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Incidence of Surgical Site Infections (SSI) in a Large Teaching Hospital in Rome, Italy.
Actual Study Start Date
:
Jul 2, 2018
Actual Primary Completion Date
:
Nov 15, 2022
Actual Study Completion Date
:
Nov 15, 2022
Outcome Measures
Primary Outcome Measures
- Incidence of surgical site infection [30 days or 90 days (prosthesis)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- patient undergoing surgery
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario "A. Gemelli" IRCCS | Rome | RM | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Laurenti Patrizia,
Chief of the Complex Operative Unit of Hospital Hygiene,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05788575
Other Study ID Numbers:
- 1956
First Posted:
Mar 29, 2023
Last Update Posted:
Mar 29, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms: