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

Last updated: June 11, 2023
Sponsor: Universitat Internacional de Catalunya
Overall Status: Completed

Phase

4

Condition

Pressure Ulcer

Treatment

Physiological Saline

Amoxicillin Clavulanate

Clinical Study ID

NCT03574090
1234
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 thesurgical intervention (except that administered to UCIES as a treatment dose of thesame process)
  • Patients allergic to the antibiotic used in the study.
  • Patients who have undergone a surgical procedure of recently opened abdomen (up to 30days before surgery), a prosthesis of synthetic material (mesh) or to which thesurgical wound can not be closed according to the surgeon's criteria.
  • Patients with an unfavorable life prognosis (ASA 5).

Study Design

Total Participants: 268
Treatment Group(s): 2
Primary Treatment: Physiological Saline
Phase: 4
Study Start date:
October 20, 2020
Estimated Completion Date:
June 11, 2023

Study 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.

Connect with a study center

  • Hospital General de Granollers

    Granollers, Barcelona 08402
    Spain

    Site Not Available

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