NCT04039750

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perforated Appendicitis

Interventions

Type	Name	Description
DRUG	antibiotic rinse with suction	antibiotic rinse with suction
PROCEDURE	suction only	no irrigation, suction only

Timeline

• Start date: 2019-07-25
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-07-31
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study