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Completed

NCT Number: NCT03574090

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

amoxicillin clavulanate

Drug

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.

Other names: 1000 mg amoxicillin and 200mg clavulanic acid.

physiological saline

Drug

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.

Other names: 500 milliliters of 0.9% Physiological Serum

Primary outcomes

  1. Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI

    Time frame: 30 days

    Evaluation of the effect of topical antibiòtic ( Amoxicillin 1000mg and 200mg of Clavulanic acid dissolved in 500 milliliters of 0.9% Physiological Serum ) prophylaxis on the incidence of Surgical Site Infection in surgery due to emergency intra-abdominal infection

Secondary outcomes

  1. reduction of hospital stay

    Time frame: 30 days

    Effect of the protocol of topical prophylaxis in the reduction of hospital stay

  2. Bacterial charge

    Time frame: 30 days

    Effect of topical prophylaxis protocol on reducing bacterial charge

  3. Bacterial resistance

    Time frame: 30 days

    Effect of topical prophylaxis protocol on Bacterial resistance

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

  • Hospital de Granollers

Registry information

Official study title

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

Acronym: PROTOP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2018
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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