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Active, Not Recruiting

NCT Number: NCT04039750

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

antibiotic rinse with suction

Drug

antibiotic rinse with suction

Other names: Clindamycin, gentamycin

suction only

Procedure

no irrigation, suction only

Primary outcomes

  1. wound complications

    Time frame: 30 days

    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

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Acronym: PA protocol

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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