Clinical trial NCT01115153: Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
Official title: Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gangrenous Appendicitis
Keywords: Acute appendicitis
Antibiotic prophylaxis
Wound infection
Nosocomial infection
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Santander
First posted: 2010-05-04
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound infection
timeFrame: 30 days
Secondary outcomes:
measure: Length of the hospital stay
timeFrame: 30 days
measure: Adverse effects treatment related
timeFrame: 30 days
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Hospital Universitario de Santander
state: Santander
Study officials:
affiliation: Universidad Industrial de Santander
name: Henry A Uscategui, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Industrial de Santander
name: Francisco Camacho, Physician
role: STUDY_DIRECTOR
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