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Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT03574090•Universitat Internacional de Catalunya

View on ClinicalTrials.gov

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

Detailed Description

Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients over 18 years of age.
•Patients who require urgent surgical intervention and who come from the emergency service
•Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.

Exclusion Criteria

•Women patients with positive pregnancy test.
•Patients with primary peritonitis and liver cirrhosis.
•Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process)
•Patients allergic to the antibiotic used in the study.
•Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria.
•Patients with an unfavorable life prognosis (ASA 5).

Locations (1)

Hospital General de Granollers

Granollers, Barcelona, Spain

Key Dates

Start Date

October 20, 2020

Primary Completion Date

May 30, 2023

Completion Date

June 11, 2023

Last Updated

June 13, 2023

Enrollment

268

ACTUAL participants

Conditions

Surgical Wound InfectionPostoperative Wound InfectionPostoperative Wound Infection Superficial IncisionalPreventive Therapy

Interventions

Amoxicillin Clavulanate

DRUG

Physiological Saline

DRUG

A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

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Surgical Wound InfectionTraumatic Wound Infection

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site

Post Cesarian Section Wound Infections At Emergency Room

Antibacterial-coated Sutures at Time of Cesarean

The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery