CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 268 enrolled
Drug / intervention
Amoxicillin Clavulanate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03574090
NCT03574090Phase 4Completed
CompareCT.gov

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

Universitat Internacional de Catalunya·interventional·Posted Jun 29, 2018·Updated Jun 13, 2023

In Brief

A Phase 4 clinical trial evaluating Amoxicillin Clavulanate and Physiological Saline for Surgical Wound Infection and 3 related conditions. Completed, enrolled 268 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy
CountriesSpain
CollaboratorsHospital de Granollers

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 29, 2018
Enrollment StartOct 20, 2020
Primary CompletionMay 30, 2023
Study CompletionJun 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.0 years ago

Interventions

Amoxicillin Clavulanatedrug

To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.

Physiological Salinedrug

To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.