Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

Launched by MARCO CATARCI · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Polihexanide SSIs Measures Bundle (PSMB), is looking at ways to prevent infections that can occur after major digestive surgeries. The study will involve about 2,000 patients from 20 surgical centers in Italy, focusing on those who are having planned surgeries on the gastrointestinal (GI) tract. Researchers want to see if a specific treatment can help reduce the risk of surgical site infections, which are infections that happen at the site of the surgery.

To participate in this trial, patients need to be adults aged 65 and older who are undergoing elective major digestive surgeries, whether done using traditional methods or minimally invasive techniques like laparoscopic or robotic surgery. Patients will need to provide their written consent to be part of the study. Throughout the trial, participants will be closely monitored, and their progress will be tracked to see how well the treatment works. It's important to note that this trial is not yet recruiting participants, as it is set to begin in July 2024 and will last until June 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients submitted to laparoscopic/robotic/open/converted major digestive surgery (upper and lower gastrointestinal resections).
• • American Society of Anesthesiologists' (ASA) class I, II, III or IV
• • Elective surgery
• • Patients' written acceptance to be included in the study.
• Exclusion Criteria:
• • American Society of Anesthesiologists' (ASA) class V
• • Urgent surgery
• • Pregnancy
• • Hyperthermic intraperitoneal chemotherapy for carcinomatosis.