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Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitario de Santander
Information provided by (Responsible Party):
Henry Uscategui Cristancho, Universidad Industrial de Santander
ClinicalTrials.gov Identifier:
NCT01115153
First received: April 19, 2010
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  Purpose

A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.


Condition Intervention
Gangrenous Appendicitis
 Other: prophylaxis
Other: therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Industrial de Santander:

Primary Outcome Measures:
  • wound infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space


Secondary Outcome Measures:
  • Length of the hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Duration in days from admission until discharge

  • Adverse effects treatment related [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Adverse effects derived from the usage of antibiotics


Enrollment: 150
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic prophylaxis
Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)
 Other: prophylaxis
single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
Active Comparator: Antibiotic treatment, wound infection
Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)
 Other: therapy
antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day

Detailed Description:

Introduction: For patients with acute gangrenous appendicitis, it is common to provide antibiotics during 5-7 days in order to reduce the incidence of infection of the surgical wound; however the benefit of such treatment has not been tested. A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.

Materials and Methods: From December 2007 to November 2009, 799 patients went through surgery after being diagnosed with acute appendicitis. Out of this set, 150 patients diagnosed with acute gangrenous appendicitis, were randomly assigned to one of two groups: control group (group A: 72 patients received a 5-day antibiotic therapy), and treatment group (group B: 78 patients received a single 1-dose of antibiotic prophylaxis). The experimental outcomes included: the incidence of infection of the surgical wound, the length of the hospital stay, and the adverse effects derived from a prolonged use of antibiotics.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study

Exclusion Criteria:

  • patients under 12 or older 65 years old
  • Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure
  • Pregnancy
  • Patients who have received antibiotic treatment within seven days before surgery
  • Patients difficult to monitor or follow up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115153

Locations
Colombia
Hospital Universitario de Santander
Bucaramanga, Santander, Colombia, 097
Sponsors and Collaborators
Universidad Industrial de Santander
Hospital Universitario de Santander
Investigators
Principal Investigator: Henry A Uscategui, Physician Universidad Industrial de Santander
Study Director: Francisco Camacho, Physician Universidad Industrial de Santander
  More Information

Publications:

Responsible Party: Henry Uscategui Cristancho, General Surgeon, Universidad Industrial de Santander
ClinicalTrials.gov Identifier: NCT01115153     History of Changes
Other Study ID Numbers: 74186942
Study First Received: April 19, 2010
Last Updated: August 22, 2011
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad Industrial de Santander:
Acute appendicitis
Antibiotic prophylaxis
Wound infection
Nosocomial infection

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gangrene
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
 Disease Attributes
Pathologic Processes
Necrosis
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013