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Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures

NCT01524081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2012-02-08

No results posted yet for this study

Summary

Aim of prospective randomized a placebo controlled study is to prove that in case of acute surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel and stomach appropriately administered antibiotic prophylaxis is effective with lower incidence of infection in surgical site and comparable risk of development of other nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to determine risk of developing nosocomial infection in the above mentioned group of patients, identify group of patients which does not benefit from prophylaxis, and compile financial costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the background for the recommended procedure with regards that such prospective study does not exist in the Czech Republic.

Conditions

  • Acute Appendicitis
  • Perforated Gastroduodenal Ulcer
  • Small Bowel Obstruction

Interventions

DRUG

Metronidazole, Cefuroxime

administration of Cefuroxime 1.5 g and Metronidazole 1g in 2 following intravenous infusions 60 minutes prior the surgery. 1. \- Cefuroxime in 100ml saline 2. \- Metronidazole in 500ml saline

DRUG

Amoxicillin (+ clavulanic acid) and Fluconazole

Administration of amoxicillin (+ clavulanic acid) 2.4 g and Fluconazole 800mg in 2 following intravenous infusions 60 minutes prior the surgery. 1. \- 2x amoxicillin in 100ml saline 2. \- Fluconazole in 500ml saline

DRUG

Placebo

Administration of saline infusion (Natrii chloridum: 9,0 g/l) 60 minutes prior the surgery 1. \- 100ml saline solution 2. \- 500ml saline solution

DRUG

Placebo

Administration of saline infusion (Natrii chloridum: 9,0 g/l) 60 minutes prior the surgery 1. \- 2x 100ml saline solution 2. \- 500ml saline solution

Sponsors & Collaborators

  • The Faculty Hospital Na Bulovce

    lead OTHER

Principal Investigators

  • Ondrej Ryska, MD · Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-07-31
Completion
2011-11-30

Countries

  • Czechia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524081 on ClinicalTrials.gov