Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

Study Overview
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Brief Summary
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The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.

Detailed Description
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This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity. Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.

Official Title
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Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

Conditions
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Perforated Appendicitis

Intervention / Treatment
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* Drug: antibiotic rinse with suction
* Procedure: suction only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18 years or younger Scheduled to undergo laparoscopic appendectomy Preoperative or intra-operative diagnosis of perforated appendicitis (PA). Willingness to undergo treatments, provide written informed consent, and participate in follow-up. Exclusion Criteria: Male or female older than 18 years of age Declined to undergo laparoscopic appendectomy Not willing to provide written informed consent or undergo randomization of treatment Pregnancy

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Patients will be randomized into 1 of 2 groups. Group A will be Antibiotic Irrigation with suction and Group B will be Suction Alone.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic irrigation with suction<br>Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery | Drug: antibiotic rinse with suction<br>* antibiotic rinse with suction<br>* Other names: Clindamycin, gentamycin;|
| Active Comparator: suction only<br>Group B: You will receive suction alone if a PA is found during surgery | Procedure: suction only<br>* no irrigation, suction only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound complications | The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms | 30 days |