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

Pro00088360

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.

2019-07-25

2024-12-01

2025-12-01

Active (not recruiting)

Early phase I

200

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'there is no masking after randomization', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-04-24