Antibiotic Use in Distal Hypospadias Repair
Completed · Not applicable
Conditions studied: Hypospadias
In brief
Hypospadias is a common condition where the opening of the penis is not located at the tip, but along the underside of the penis. It is estimated to occur in 1/300 live male births, making it one of the most common birth defects. Degrees of hypospadias ranged from minor to severe depending on the location of the opening. Surgical repair is often required and involves placement of a catheter for the urine to drain with known urinary colonization found on prior retrospective studies. The current practice of using preventative antibiotics as long as the catheter is in place is conflicting with resent studies that show antibiotics may not be necessary to prevent urinary tract infections (UTIs). The purpose of this study was to see how common symptomatic UTIs were after hypospadias repair surgery; and to see whether routine antibiotic use after surgery affected the rate of UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal hypospadias repair. The research coordinator made follow-up phone calls with the family and the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3 month post surgical visit.
Key facts
- Study ID
- NCT03275519
- Run by
- Arkansas Children's Hospital Research Institute
- People needed
- 48
- Starts
- 2015-01-19
- Expected to finish
- 2017-04-19
- Last updated by the study team
- 2017-09-07
Who can join
Age: 0 and older, up to 6. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Males undergoing primary distal hypospadias repair with open urethral stent drainage.
You may not qualify if…
- Males undergoing fistula repair or glandular hypospadias repair without incontinent urethral stent drainage and hypospadias repair of mid or more proximal degrees of hypospadias were excluded from this study.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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