Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis (PA protocol)

The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.

Study Overview

• Status: Recruiting
• Conditions: Perforated Appendicitis
• Intervention / Treatment: Drug: antibiotic rinse with suction; Procedure: suction only

Detailed Description

This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity.

Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robert Gates, MD; Phone Number: 864-797-7400; Email: robert.gates@prismahealth.org
• Study Contact Backup: Name: Sharon Haire, NP; Phone Number: 864-797-7400

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health - Upstate
      • Contact: Sharon Haire, NP; Phone Number: 864-797-7400
      • Contact: Robert Gates, MD; Phone Number: 864-797-7400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, age 18 years or younger
2. Scheduled to undergo laparoscopic appendectomy
3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA).
4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.

Exclusion Criteria:

1. Male or female older than 18 years of age
2. Declined to undergo laparoscopic appendectomy
3. Not willing to provide written informed consent or undergo randomization of treatment
4. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic irrigation with suction; Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery	Drug: antibiotic rinse with suction; antibiotic rinse with suction; Other Names: Clindamycin, gentamycin
Active Comparator: suction only; Group B: You will receive suction alone if a PA is found during surgery	Procedure: suction only; no irrigation, suction only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound complications	The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms	30 days

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Robert Gates, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Bacterial Agents; Clindamycin; Gentamicins
• Other Study ID Numbers: Pro00088360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No