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Anti-bacterial Agent

Antibiotic Irrigation for Appendicitis (PA protocol Trial)

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

PA protocol Trial Summary

This trial will compare two methods of preventing infection during surgery for appendicitis. One method uses a suction device without irrigation and the other uses a gentamicin/clindamycin solution.

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.Check my eligibility

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.See study design

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.

PA protocol Trial 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.

PA protocol Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

wound complications

PA protocol 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 / 4Eligibility criteria met

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Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor

82 Previous Clinical Trials

42,738 Total Patients Enrolled

Robert Gates, MDPrincipal InvestigatorPrisma Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed using suction in combination with antibiotics for medical treatments?

"The safety rating of antibiotic rinse with suction is a 2, as there has only been preliminary research conducted to assess its security. Consequently, no proof exists in favor of the effectiveness at this time."

Answered by AI

Is this experiment incorporating elderly individuals in its sample size?

"To be eligible for enrollment in this medical trial, patients must fall within the 0 to 18 year age bracket. There are 28 trials specifically designed for minors and 51 that focus on adults over 65 years old."

Answered by AI

How many participants have enrolled in this clinical investigation?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial is currently enrolling participants, with the initial posting on July 25th 2019 and last update on August 31st 2022. This study requires 200 patients from 1 site to take part in it's proceedings."

Answered by AI

Have any other trials employed the combination of antibiotic rinse and suction?

"Presently, there are 15 studies on antibiotic rinse with suction in progress. 6 of these have reached Phase 3 trials and can be found at 95 different sites located mainly in Singapore and New South Wales."

Answered by AI

Does this investigation currently have room to admit additional participants?

"Affirmative. Clinicaltrials.gov has evidence that this research trial, initially posted on July 25th 2019 and last updated August 31st 2022, is now recruiting 200 individuals at a single medical centre."

Answered by AI

What medical conditions can antibiotic lavage with suction be used to manage?

"A combination of antibiotic suction rinse can be employed to combat bacterial and anaerobic infections, such as acquired valvular dysfunction, surgically constructed systemic-pulmonary shunt, and viridans group streptococci."

Answered by AI

Is it possible for me to register for this medical experiment?

"This medical trial is hoping to enrol 200 minors aged 0-18 that have appendicitis and are scheduled for a laparoscopic procedure. Both genders will be considered, so long as they do not exceed 18 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04039750.

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