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

Phase 2

Active, not recruiting

• Conditions: Perforated Appendicitis
• Interventions: Drug: antibiotic rinse with suction; Procedure: suction only

• Registration Number: NCT04039750
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male or female, age 18 years or younger
2. Scheduled to undergo laparoscopic appendectomy
3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA).
4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.

Exclusion Criteria

1. Male or female older than 18 years of age
2. Declined to undergo laparoscopic appendectomy
3. Not willing to provide written informed consent or undergo randomization of treatment
4. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic irrigation with suction	antibiotic rinse with suction	Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery
suction only	suction only	Group B: You will receive suction alone if a PA is found during surgery

Primary Outcome Measures

Name	Time	Method
wound complications	30 days	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

Trial Locations

Locations (1)

Prisma Health - Upstate; 🇺🇸 Greenville, South Carolina, United States