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

Universidad Industrial de Santander

Status: Completed

Conditions: Gangrenous Appendicitis

Treatments: Other: prophylaxis; Other: therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01115153

74186942

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Antibiotic prophylaxis

Experimental group

Description:

Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)

Treatment:

Other: prophylaxis

Antibiotic treatment, wound infection

Active Comparator group

Description:

Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)

Treatment:

Other: therapy