Clinical trial NCT02724410: Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis
Official title: Home Intravenous Versus Oral Antibiotics Following Appendectomy for Perforated Appendicitis in Children, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Appendicitis
Keywords: appendectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 82
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Detailed description: Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.

Eligibility criteria: Inclusion Criteria:

* Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

Exclusion Criteria:

* Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.

Primary outcomes:
measure: Number of Participants With Postoperative Abscess
timeFrame: Thirty days after appendectomy
measure: Number of Participants With Wound Infections
timeFrame: Thirty days following appendectomy
measure: Number Participants With Readmission Within 30 Days
timeFrame: Thirty days following appendectomy
measure: Hospital Charge
timeFrame: Thirty days following appendectomy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brant T Heniford, M.D.
role: PRINCIPAL_INVESTIGATOR
References: