Gangrenous Appendicitis Clinical Trial
Official title:
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)
| Verified date | August 2011 |
| Source | Universidad Industrial de Santander |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Colombia: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | February 2010 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Hospital Universitario de Santander | Bucaramanga | Santander |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Industrial de Santander | Hospital Universitario de Santander |
Colombia,
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Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001439. Review. — View Citation
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* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Length of the hospital stay | Duration in days from admission until discharge | 30 days | Yes |
| Secondary | Adverse effects treatment related | Adverse effects derived from the usage of antibiotics | 30 days | Yes |