UnknownPhase 4

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

Italy2,000 participantsStarted 2024-07-01

Plain-language summary

This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical Site Infections rate

Timeframe: 60 days after surgery

Incisional (superficial and deep) Surgical Site Infections rate

Timeframe: 60 days after surgery

Infectious morbidity rates

Timeframe: 60 days after surgery

Trial details

NCT IDNCT06338163

SponsorMarco Catarci

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Marco Scatizzi, MD

+393492197687 marcoscatizzi60@gmail.com

View on ClinicalTrials.gov More Surgical Site Infection trials