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

NCT04039750 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00088360
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perforated Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Antibiotic irrigation with suction

EXPERIMENTAL

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

Drug: antibiotic rinse with suction

suction only

ACTIVE COMPARATOR

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

Procedure: suction only

Interventions

antibiotic rinse with suction DRUG

antibiotic rinse with suction

Also known as: Clindamycin, gentamycin

Antibiotic irrigation with suction

suction only PROCEDURE

no irrigation, suction only

suction only

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Male or female older than 18 years of age
• Declined to undergo laparoscopic appendectomy
• Not willing to provide written informed consent or undergo randomization of treatment
• Pregnancy

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Suction; Clindamycin; Gentamicins

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Aminoglycosides

Study Officials

• Robert Gates, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: there is no masking after randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 31, 2019
• Study Start: July 25, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)