Antibiotic Irrigation for Appendicitis

(PA protocol Trial)

Overseen By Sharon Haire, NP

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Prisma Health-Upstate

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Antibiotic Rinse with Suction for appendicitis?

Research suggests that using an antibiotic solution for irrigation during appendicitis surgery may help reduce surgical site infections, although the effectiveness can vary depending on the type of solution used. ^{1 2 3 4 5}

Is antibiotic irrigation generally safe for humans?

The use of antibiotic irrigation in surgeries, including appendicitis, has been discussed in medical literature, but there is a lack of well-designed studies to definitively assess its safety. Some studies suggest low complication rates when antibiotics are used, but more controlled trials are needed to confirm safety. ^{1 2 5 6 7}

How does the treatment 'Antibiotic Rinse with Suction' differ from other treatments for appendicitis?

The 'Antibiotic Rinse with Suction' treatment for appendicitis is unique because it involves using an antibiotic solution to wash out the infected area during surgery, which is different from the standard approach of just using suction to remove fluids. This method aims to reduce the risk of infections after surgery by directly applying antibiotics to the affected area. ^{1 2 3 4 5}

Research Team

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

Exclusion Criteria

I am not willing to sign consent or be randomly assigned a treatment.

I am over 18 years old.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo laparoscopic appendectomy with either antibiotic irrigation and suction or suction alone

1 day

1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for wound complications and IAA for 30 days post-surgery

4 weeks

Regular follow-up visits as needed

Treatment Details

Interventions

• Antibiotic Rinse with Suction
• Suction Only

Trial Overview The 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

Group I: Antibiotic irrigation with suction Experimental Treatment 1 Intervention

Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery

Group II: suction only Active Control 1 Intervention

Group B: You will receive suction alone if a PA is found during surgery

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Irrigation Versus Suction Alone During Laparoscopic Appendectomy for Uncomplicated Acute Appendicitis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Irrigation Versus Suction Alone in Laparoscopic Appendectomy: Is Dilution the Solution to Pollution? A Systematic Review and Meta-Analysis. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Infectious Complications After Laparoscopic Appendectomy in Pediatric Patients with Perforated Appendicitis: Is There a Difference in the Outcome Using Irrigation and Suction Versus Suction Only? Results of a Multicentric International Retrospective Study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Aspiration versus peritoneal lavage in appendicitis: a meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Using antimicrobial solution for irrigation in appendicitis to lower surgical site infection rates. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Appendicitis in children. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Antibiotic irrigations. A plea for controlled clinical trials. [2019]