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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Universidad Industrial de Santander

Current Primary Outcome: wound infection [ Time Frame: 30 days ]

Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of the hospital stay [ Time Frame: 30 days ]
    Duration in days from admission until discharge
  • Adverse effects treatment related [ Time Frame: 30 days ]
    Adverse effects derived from the usage of antibiotics


Original Secondary Outcome: Same as current

Information By: Universidad Industrial de Santander

Dates:
Date Received: April 19, 2010
Date Started: December 2007
Date Completion:
Last Updated: August 22, 2011
Last Verified: August 2011