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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zuzana Serclova, MD, The Faculty Hospital Na Bulovce
ClinicalTrials.gov Identifier:
NCT01524081
First received: January 30, 2012
Last updated: February 7, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Acute Appendicitis
Perforated Gastroduodenal Ulcer
Small Bowel Obstruction
Drug: Metronidazole, Cefuroxime
Drug: Amoxicillin (+ clavulanic acid) and Fluconazole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Phase 3 Study of Antibiotic Prophylaxis Use Prior Emergent Surgery, Because of Acute Appendicitis

Resource links provided by NLM:


Further study details as provided by The Faculty Hospital Na Bulovce:

Primary Outcome Measures:
  • Surgical Site Infection rate [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    The evidence of Surgical Site Infection (SSI) using clinical definition CDC/NHSN)


Secondary Outcome Measures:
  • Hospital Acquired Infection /HAI/ [ Time Frame: 60 days after surgery ] [ Designated as safety issue: Yes ]
    Incidence of HAIs during the 60 days after surgery. Diagnosis confirmed using criteria CDC/NHSN


Enrollment: 187
Study Start Date: July 2008
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APPE - antibiotic prophylaxis
Patients indicated for emergent appendectomy with antibiotic prophylaxis
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
Other Names:
  • Zinacef 750mg (Cefuroxime 750mg, Glaxo Group Ltd., UK)
  • Metronidazol 500mg (Metronidazole 500mg; B.Braun Melsungen AG, Germany)
Experimental: GERD - antibiotic prophylaxis
Patients indicated for emergent surgery due to gastroduodenal perforation with antibiotic prophylaxis.
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
Other Names:
  • Amiksiklav 1,2 g (amoxicillinum natricum 1000mg, acidum clavulanicum 200mg; Lek Pharmaceuticals d.d., Ljubljana, Slovenia
  • Fluconazol 200ml (fluconazolum 400mg; Baxter; Czech Republic)
Experimental: ILEUS - antibiotic prophylaxis
Patients indicated for emergent due to small bowel obstruction with antibiotic prophylaxis
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
Other Names:
  • Zinacef 750mg (Cefuroxime 750mg, Glaxo Group Ltd., UK)
  • Metronidazol 500mg (Metronidazole 500mg; B.Braun Melsungen AG, Germany)
Placebo Comparator: APPE - placebo
Patients indicated for emergent appendectomy without antibiotic prophylaxis. Placebo (saline) was administrated.
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
Other Name: F1/1 (saline solution; 0,9% NaCl; Baxter Czech Republic)
Placebo Comparator: GERD - placebo
Patients indicated for emergent surgery due to gastroduodenal perforation without antibiotic prophylaxis. Placebo (saline) was administrated.
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
Other Name: F1/1 (saline solution; 0,9% NaCl; Baxter Czech Republic)
Placebo Comparator: ILEUS - placebo
Patients indicated for emergent due to small bowel obstruction without antibiotic prophylaxis. Placebo (saline) was administrated.
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
Other Name: F1/1 (saline solution; 0,9% NaCl; Baxter Czech Republic)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient older > 18 years
  • Patient indicated for emergent surgery for:

acute appendicitis / perforated gastric or duodenal ulcer / small bowel obstruction

  • The patient can understand the aim of the study and sign informed consent (including language barriers)
  • The diagnose is confirmed intraoperatively

Exclusion Criteria:

  • Refused the participation in the study and
  • uninsured self-payers
  • Patients with known allergy to the substance administered during the study or chronic medication contraindicated with study drug
  • Pregnant or breastfeeding women
  • Use of antibiotics in the last 2 weeks
  • Known serious illness (heart failure, renal failure, liver failure, CNS disorders)
  • Signs of infectious mononucleosis and risk of infectious endocarditis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524081

Locations
Czech Republic
Faculty Hospital Bulovka
Prague, Czech Republic, 18081
Sponsors and Collaborators
The Faculty Hospital Na Bulovce
Investigators
Principal Investigator: Ondrej Ryska, MD Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic
  More Information

No publications provided

Responsible Party: Zuzana Serclova, MD, Head of ICU - Department of Surgery, Principal Investigator, The Faculty Hospital Na Bulovce
ClinicalTrials.gov Identifier: NCT01524081     History of Changes
Other Study ID Numbers: FNB_ATB
Study First Received: January 30, 2012
Last Updated: February 7, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by The Faculty Hospital Na Bulovce:
antibiotic prophylaxis
emergent surgery
surgical site infection

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intestinal Obstruction
Peptic Ulcer
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Duodenal Diseases
Stomach Diseases
Amoxicillin
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Clavulanic Acids
Clavulanic Acid
Fluconazole
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on April 17, 2014