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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gangrenous Appendicitis

Intervention / Treatment
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* Other: prophylaxis
* Other: therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic prophylaxis<br>Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery) | Other: prophylaxis<br>* single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV<br>|
| Active Comparator: Antibiotic treatment, wound infection<br>Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery) | Other: therapy<br>* antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the hospital stay | Duration in days from admission until discharge | 30 days | 
| Adverse effects treatment related | Adverse effects derived from the usage of antibiotics | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound infection, Acute appendicitis, Antibiotic prophylaxis, Nosocomial infection