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Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery
Sponsor: Marco Catarci
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2024-07-01
Completion Date
2025-09-30
Last Updated
2024-04-04
Healthy Volunteers
No
Interventions
Polihexanide-based bundle
Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products
Standard bundle
Pre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution
Locations (3)
OSpedale Santa Maria Annunziata
Florence, FI, Italy
Ospedale Civile di Macerata
Macerata, MC, Italy
Ospedale Sandro Pertini
Roma, RM, Italy