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

Prisma Health-Upstate

Status and phase: Active, not recruiting; Phase 2

Conditions: Perforated Appendicitis

Treatments: Drug: antibiotic rinse with suction; Procedure: suction only

Study type: Interventional

Funder types: Other

Identifiers

NCT04039750

Pro00088360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Antibiotic irrigation with suction

Experimental group

Description:

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

Treatment:

Drug: antibiotic rinse with suction

suction only

Active Comparator group

Description:

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

Treatment:

Procedure: suction only