Prophylactic Antibiotics or Placebo After Hypospadias Repair

NCT02096159 ↗

Active not recruiting 93 enrolled Ann & Robert H Lurie Children's Hospital of Chicago The Hospital for Sick Children · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

Timeline

Start: 2014-03
Primary completion: 2018-12
Completion: 2025-08

Outcome

Missed primary endpoint

paper In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid-to-distal hypospadias repair. PMID 35144885 ↗

paper Infection or urethroplasty complications occurred in 10 of 45 boys (22%) assigned to receive antibiotic prophylaxis as compared with 5 of 48 (10%) who received placebo (relative risk [RR], 2.1; 95% confidence interval [CI], 0.8 to 5.8; p = 0.16). PMID 35144885 ↗

Publications

Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	trimethoprim-sulfamethoxazole	Unknown	4 mg/kg	Oral