NCT05788575

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,424

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

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

July 2, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
Last Updated

September 27, 2024

Status Verified

March 1, 2023

Enrollment Period

4.4 years

First QC Date

March 15, 2023

Last Update Submit

September 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical site infection

    30 days or 90 days (prosthesis)

Interventions

surgeryPROCEDURE

any surgery that an inpatient has undergone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hospitalized patients undergoing surgery

You may qualify if:

  • patient undergoing surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Complex Operative Unit of Hospital Hygiene

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

July 2, 2018

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

September 27, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations