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NCT03275519 · ClinicalTrials.gov registry record · NA
Antibiotic Use in Distal Hypospadias Repair
A NA study, sponsored by Arkansas Children's Hospital Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03275519: Completed NA study, sponsored by Arkansas Children's Hospital Research Institute.
NCT03275519 is a NA study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03275519, a NA study, has completed, sponsored by Arkansas Children's Hospital Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.
Interventions
- OTHER Randomization to not receive prophylactic antibiotics after surgery.
- OTHER Randomization to receive prophylactic antibiotics after surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-01-19 |
| Est. Completion | 2017-04-19 |
| Phase | NA |
What the finished NCT03275519 record still lists
NCT03275519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Randomization to not receive prophylactic antibiotics after surgery. is the first listed.
NCT03275519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03275519 about?
NCT03275519 is a clinical study titled "Antibiotic Use in Distal Hypospadias Repair". 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 lo...
What is the current status of trial NCT03275519?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2015-01-19. Estimated completion is 2017-04-19.
What interventions are being tested in trial NCT03275519?
The interventions under investigation include: Randomization to not receive prophylactic antibiotics after surgery. (OTHER), Randomization to receive prophylactic antibiotics after surgery (OTHER).
Who is sponsoring clinical trial NCT03275519?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03275519's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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