Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-26 @ 7:16 AM
Study NCT ID:
NCT02096159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2014-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotics or Placebo After Hypospadias Repair
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPHY
Brief 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.
Detailed Description:
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: