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

Perforated Appendicitis Clinical Trial

— PA protocol  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04039750
• Other study ID #: Pro00088360
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 25, 2019
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis
• Wound Infection

Intervention

Drug:
• antibiotic rinse with suction
antibiotic rinse with suction

Procedure:
• suction only
no irrigation, suction only

Locations

Country	Name	City	State
United States	Prisma Health - Upstate	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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