Last reviewed · How we verify

NCT03574090: PROTOP

Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

Completed Phase 4 Last updated 13 June 2023
What this trial tests

Phase 4 trial testing Amoxicillin Clavulanate in Surgical Wound Infection in 268 participants. Completed in 11 June 2023.

Timeline
20 October 2020
Primary endpoint
30 May 2023
11 June 2023

Quick facts

Lead sponsorUniversitat Internacional de Catalunya
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment268
Start date20 October 2020
Primary completion30 May 2023
Estimated completion11 June 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universitat Internacional de Catalunya — full company profile →

Who can join

18 and older, any sex, with Surgical Wound Infection or Postoperative Wound Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Antimicrobial approach of abdominal post-surgical infections.
    Fiore M, Corrente A, Di Franco S, Alfieri A, et al · · 2023 · cited 6× · PMID 38222012 · DOI 10.4240/wjgs.v15.i12.2674

Verify or expand the search:

Other trials of Amoxicillin Clavulanate

Trials testing the same drug.

Other recruiting trials for Surgical Wound Infection

Currently open trials in the same condition.

Other Universitat Internacional de Catalunya trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03574090.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing