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

NCT06338163 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection
  • Surgical Procedures, Operative

Interventions

COMBINATION_PRODUCT

Polihexanide-based bundle

Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products

COMBINATION_PRODUCT

Standard bundle

Pre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution

Sponsors & Collaborators

  • Associazione Chirurghi Ospedalieri Italiani

    collaborator OTHER

  • Marco Catarci

    lead OTHER

Principal Investigators

  • Marco Catarci, MD, FACS · Associazione Chirurghi Ospedalieri Italiani

  • Massimo Sartelli, MD · Ospedale di Macerata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06338163 on ClinicalTrials.gov