Antibiotic Irrigation for Appendicitis

(PA protocol Trial)

Overseen By Sharon Haire, NP

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Prisma Health-Upstate

Disqualifiers: Older than 18, Pregnancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce infections after surgery for children with a burst appendix. It compares a special antibiotic rinse with suction to using only suction during surgery. The goal is to determine if the rinse more effectively prevents infections. Children needing surgery for a burst appendix (perforated appendicitis) and willing to try this new method can participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown mixed results for using antibiotics during appendicitis surgery. Some studies suggest antibiotics can reduce complications, but more research is needed to confirm their safety. One review found that an antibiotic solution resulted in an infection rate of about 0.5%, which appears promising. However, other research indicates that using only suction, without antibiotics, might lower the risk of infections and abscesses.

In summary, while antibiotics might help in some cases, they aren't always proven better than suction alone. More research is needed to confirm their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the antibiotic irrigation technique for appendicitis because it introduces a new method of delivering antibiotics directly to the affected area during surgery. Unlike standard treatment options, which typically involve systemic antibiotics, this method uses a targeted rinse that could reduce the overall antibiotic exposure and potentially minimize side effects. Additionally, by combining this rinse with suction, the procedure might more effectively clear infected tissue, possibly leading to faster recovery times and reduced risk of complications. Meanwhile, the suction-only approach serves as a comparator to highlight the added benefits of the antibiotic rinse.

What evidence suggests that this trial's treatments could be effective for preventing postoperative wound infections in appendicitis?

This trial will compare antibiotic irrigation with suction to suction alone during appendicitis surgery. Studies have shown mixed results regarding antibiotic washes in this context. Some research suggests that washing the area with an antibiotic solution might reduce infections at the surgery site. However, other studies found no significant difference in infection rates between using antibiotics and using suction alone. One study even suggested that suction alone might result in fewer abscesses and wound infections. Although there might be some benefits, current evidence does not strongly support using antibiotic washes over suction alone to prevent infections after appendicitis surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert Gates, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/antibiotic-irrigation-for-appendicitis-93f5e

Antibiotic Irrigation for Appendicitis (PA protocol Trial) Research suggests that using an antibiotic solution for irrigation during appendicitis surgery may help reduce surgical site infections, although the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10961855/

Effect of intraoperative abdominal lavage versus suction ... No evidence has been found that the use of abdominal lavage in the treatment of postoperative infectious complications after appendectomy is superior to ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961009005790

Using antimicrobial solution for irrigation in appendicitis to ... Results of this retrospective review indicate that a suction-only approach significantly decreased rates of abscess formation and wound infections compared to ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/12130/peritoneal_irrigation_vs_suction_alone_during.6.aspx

Peritoneal irrigation vs suction alone during pediatric... We found no significant difference in the incidence of postoperative intraabdominal abscess, wound infection, and the length of hospitalization between 2 group, ...

5. scirp.org scirp.org/journal/paperinformation?paperid=142873

Does Massive Irrigation Reduce the Risk of Intra ... Conclusions: Massive intra-abdominal irrigation during LA for perforated appendicitis in children may be effective in preventing PO-IAA.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6354188/

Meta‐analysis of peritoneal lavage in appendicectomy - PMC Conclusion. There is no evidence of benefit of lavage over suction for postoperative infective complications, and no individual study demonstrated a significant ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12341265/

Role of intraoperative antibiotics wound irrigation in ... A previous systematic review indicated an SSI rate of 9.8% in patients undergoing appendectomy with normal saline (0.9%) irrigation and 0.5% ...

8. globalrph.com globalrph.com/2024/03/abdominal-lavage-in-appendicitis/

Abdominal Lavage Effectiveness In Appendicitis Recent meta-analyses indicate that although lavage may improve operative time, its impact on IAA is inconclusive and may even elevate the risk in children.