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

Not Applicable

Completed

• Conditions: Gangrenous Appendicitis
• Interventions: Other: prophylaxis; Other: therapy

• Registration Number: NCT01115153
• Lead Sponsor: Universidad Industrial de Santander

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 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic prophylaxis	prophylaxis	Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)
Antibiotic treatment, wound infection	therapy	Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)

Primary Outcome Measures

Name	Time	Method
wound infection	30 days	Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space

Secondary Outcome Measures

Name	Time	Method
Length of the hospital stay	30 days	Duration in days from admission until discharge
Adverse effects treatment related	30 days	Adverse effects derived from the usage of antibiotics

Trial Locations

Locations (1)

Hospital Universitario de Santander; 🇨🇴 Bucaramanga, Santander, Colombia