What side effects are associated with this type of intervention?

The most common treatments for appendicitis, particularly antibiotic irrigation with gentamicin and clindamycin, can have several side effects. Gentamicin may cause nephrotoxicity and ototoxicity, while clindamycin can lead to gastrointestinal disturbances, including diarrhea and potentially severe Clostridioides difficile infection. Local application of these antibiotics may reduce systemic side effects but can still cause localized irritation or allergic reactions.

What prior FDA approvals exist?

The FDA has approved various antibiotics for the treatment of appendicitis, particularly for cases involving infection or risk of infection. Commonly used antibiotics include broad-spectrum agents such as piperacillin-tazobactam, cephalosporins, and metronidazole. While specific FDA approvals for local antibiotic applications like gentamicin/clindamycin irrigation in appendicitis are not detailed, these antibiotics are widely used in clinical practice for their efficacy in preventing postoperative infections. The study of gentamicin/clindamycin solution for local antibiotic application during laparoscopic appendectomy represents an innovative approach to reducing wound infections and intra-abdominal abscesses in pediatric patients with perforated appendicitis.

What other types of research exist?

Promising novel alternatives to antibiotic irrigation for appendicitis patients include: 1) Use of antimicrobial-coated implants or materials that reduce bacterial adherence and infection risk. 2) Application of hydrophilic coatings on surgical instruments that absorb and release antibiotics locally. 3) Implementation of advanced wound care techniques such as negative pressure wound therapy (NPWT) to enhance healing and reduce infection rates. 4) Utilization of bacteriophage therapy, which targets specific bacterial pathogens without affecting the normal microbiota. 5) Adoption of enhanced recovery protocols that optimize perioperative care and minimize infection risks.

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Anti-bacterial Agent

Antibiotic Irrigation for Appendicitis (PA protocol Trial)

Phase 2

Waitlist Available

Led By Robert Gates, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo laparoscopic appendectomy

Male or female, age 18 years or younger

Must not have

Not willing to provide written informed consent or undergo randomization of treatment

Declined to undergo laparoscopic appendectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions to the antibiotic solution, such as allergic responses or irritation at the site where surgery was done. The exact side effects will depend on how each child reacts to the antibiotic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a laparoscopic surgery to remove my appendix.

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I am 18 years old or younger.

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My appendix was found to be ruptured before or during surgery.

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My appendix was found to be ruptured before or during surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have chosen not to have surgery to remove my appendix.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

wound complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for appendicitis is surgical removal of the appendix (appendectomy), which can be performed via open surgery or laparoscopically. Antibiotic therapy is also crucial, especially in cases of perforated appendicitis, to prevent and treat infections. Gentamicin and clindamycin are antibiotics used for their broad-spectrum activity against gram-negative and anaerobic bacteria, respectively. When used in local antibiotic irrigation during surgery, these antibiotics directly target the infected area, reducing bacterial load and preventing postoperative infections. This localized approach minimizes systemic side effects and enhances the effectiveness of infection control, which is vital for improving patient outcomes and reducing complications in appendicitis treatment.