Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Study Overview
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Brief Summary
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After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

Detailed Description
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The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Official Title
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Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Conditions
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Perforated Appendicitis, Postoperative Infection

Intervention / Treatment
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* Drug: Piperacillin, Tazobactam Drug Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postoperative Perforated Appendicitis (documented by intraoperative photo) Postoperative Laparoscopic Appendectomy Exclusion Criteria: Nonperforated Gangrenous Appendicitis Nonperforated Purulent Appendicitis Open Appendectomy

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2-drug Therapy<br>ceftriaxone/metronidazole | |
| Experimental: 1-drug Therapy<br>piperacillin-tazobactam | Drug: Piperacillin, Tazobactam Drug Combination<br>* Single drug therapy<br>* Other names: Zosyn;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Intra-abdominal Abscess | Intra-abdominal abscess documented by ultrasound or computerized tomography | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Surgical Site Infection | surgical site infections including superficial port site infection | 30 days | 
| Postoperative Readmission | readmission within 30 days for any gastrointestinal complaints or infectious complications | 30 days | 
| Postoperative Antibiotic Charge | any additional antibiotics prescribed due to infectious complications | 30 days | 
| Interventions for postoperative abscess | drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics | 30 days |