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