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

NCT01524081 | Completed Phase 3

• 1 other identifier: FNB_ATB
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

antibiotic prophylaxis; emergent surgery; surgical site infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection rate

  The evidence of Surgical Site Infection (SSI) using clinical definition CDC/NHSN)

  30 days after surgery

Secondary Outcomes (1)

• Hospital Acquired Infection /HAI/

  60 days after surgery

Study Arms (6)

APPE - antibiotic prophylaxis

EXPERIMENTAL

Patients indicated for emergent appendectomy with antibiotic prophylaxis

Drug: Metronidazole, Cefuroxime

GERD - antibiotic prophylaxis

EXPERIMENTAL

Patients indicated for emergent surgery due to gastroduodenal perforation with antibiotic prophylaxis.

Drug: Amoxicillin (+ clavulanic acid) and Fluconazole

ILEUS - antibiotic prophylaxis

EXPERIMENTAL

Patients indicated for emergent due to small bowel obstruction with antibiotic prophylaxis

Drug: Metronidazole, Cefuroxime

APPE - placebo

PLACEBO COMPARATOR

Patients indicated for emergent appendectomy without antibiotic prophylaxis. Placebo (saline) was administrated.

Drug: Placebo

GERD - placebo

PLACEBO COMPARATOR

Patients indicated for emergent surgery due to gastroduodenal perforation without antibiotic prophylaxis. Placebo (saline) was administrated.

Drug: Placebo

ILEUS - placebo

PLACEBO COMPARATOR

Patients indicated for emergent due to small bowel obstruction without antibiotic prophylaxis. Placebo (saline) was administrated.

Drug: Placebo

Interventions

Metronidazole, Cefuroxime DRUG

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

Also known as: Zinacef 750mg (Cefuroxime 750mg, Glaxo Group Ltd., UK), Metronidazol 500mg (Metronidazole 500mg; B.Braun Melsungen AG, Germany)

APPE - antibiotic prophylaxis; ILEUS - antibiotic prophylaxis

Amoxicillin (+ clavulanic acid) and Fluconazole DRUG

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

Also known as: Amiksiklav 1,2 g (amoxicillinum natricum 1000mg, acidum clavulanicum 200mg; Lek Pharmaceuticals d.d., Ljubljana, Slovenia, Fluconazol 200ml (fluconazolum 400mg; Baxter; Czech Republic)

GERD - antibiotic prophylaxis

Placebo DRUG

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

Also known as: F1/1 (saline solution; 0,9% NaCl; Baxter Czech Republic)

APPE - placebo; ILEUS - placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Faculty Hospital Na Bulovce: lead

Study Sites (1)

Faculty Hospital Bulovka

Prague, 18081, Czechia

Location

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection

Interventions

Metronidazole; Cefuroxime; Benchmarking; Amoxicillin; Clavulanic Acid; Fluconazole; Saline Solution

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Ampicillin; Penicillin G; Penicillins; Clavulanic Acids; Triazoles; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ondrej Ryska, MD

  Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ICU - Department of Surgery, Principal Investigator

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 8, 2012

Record last verified: 2012-01

Locations

CZ (1)