Reducing surgical site infections in colorectal surgery
Evaluation of the Application and Efficacy of Prevention Measures for Surgical Site Infection in Elective Colorectal Surgery.
This study is testing a new set of safety steps to see if they can help prevent infections after colorectal surgeries in hospitals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60000 (estimated) |
| Sex | All |
| Sponsor | Hospital de Granollers Academic / other |
| Locations | 1 site (Granollers, Barcelona) |
| Trial ID | NCT04496635 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a specific bundle of preventative measures designed to reduce surgical site infections (SSI) in elective colorectal surgeries. Utilizing data from the Nosocomial Infection Surveillance Program in Catalonia (VINCat), the study compares SSI rates before and after the implementation of these measures across various hospitals. The methodology includes a logistic regression model to analyze the odds of SSI occurrence, with a focus on hospitals classified by size. The study involves active surveillance and post-discharge monitoring to ensure comprehensive data collection and patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective colon or rectal surgery.
Not a fit: Patients undergoing 'dirty' surgeries, such as those with peritonitis or multiple procedures during the same surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of surgical site infections in patients undergoing colorectal surgery.
How similar studies have performed: Other studies have shown success with similar preventative measures in reducing surgical site infections, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Colon or rectal elective surgery.
Exclusion Criteria:
* Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention
Where this trial is running
Granollers, Barcelona
- Hospital General de Granollers — Granollers, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Josep M Badia-Perez, MD, PhD — Fundació Hospital General de Granollers
- Study coordinator: Gemma Molist, MD, PHD
- Email: gmolist@fphag.org
- Phone: +348425000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.