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Completed

NCT Number: NCT01115153

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

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.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Santander

Bucaramanga, Santander Department, 097, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prophylaxis

Other

single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV

Therapy

Other

antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day

Primary outcomes

  1. wound infection

    Time frame: 30 days

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

Secondary outcomes

  1. Length of the hospital stay

    Time frame: 30 days

    Duration in days from admission until discharge

  2. Adverse effects treatment related

    Time frame: 30 days

    Adverse effects derived from the usage of antibiotics

Sponsors and collaborators

Lead sponsor

Universidad Industrial de Santander

Other

Collaborators

  • Hospital Universitario de Santander

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
May 4, 2010
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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