Trial Summary
What is the purpose of this trial?
This trial is testing if washing the surgical area with an antibiotic solution during appendix surgery helps prevent infections better than just using suction. It focuses on children with a burst appendix to see if this method reduces post-surgery infections.
Research Team
RG
Robert Gates, MD
Principal Investigator
Prisma Health
Eligibility Criteria
This trial is for children and teenagers up to 18 years old who are scheduled for laparoscopic surgery due to perforated appendicitis. Participants must be willing to follow the treatment plan and come back for check-ups. Pregnant individuals or those not consenting to the study's procedures cannot join.Inclusion Criteria
Willingness to undergo treatments, provide written informed consent, and participate in follow-up.
I am scheduled for a laparoscopic surgery to remove my appendix.
Willingness to undergo treatments, provide written informed consent, and participate in follow-up
See 3 more
Exclusion Criteria
I am not willing to sign consent or be randomly assigned a treatment.
I am over 18 years old.
Pregnancy
See 1 more
Treatment Details
Interventions
- Antibiotic Rinse with Suction (Anti-bacterial Agent)
- Suction Only (Procedure)
Trial OverviewThe study is testing if rinsing out the appendix area with antibiotics (gentamicin/clindamycin) during surgery helps prevent infections better than just using suction without any rinse. Kids in this study will randomly get one of these two treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Antibiotic irrigation with suctionExperimental Treatment1 Intervention
Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery
Group II: suction onlyActive Control1 Intervention
Group B: You will receive suction alone if a PA is found during surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prisma Health-Upstate
Lead Sponsor
Trials
91
Recruited
47,500+
Mark S. O’Halla
Prisma Health-Upstate
Chief Executive Officer since 2019
MBA
Patrice M. Weiss
Prisma Health-Upstate
Chief Medical Officer
MD