Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03275519
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2017-08-11
Brief Title:
Antibiotic Use in Distal Hypospadias Repair
Sponsor:
Arkansas Childrens Hospital Research Institute
Organization:
Arkansas Childrens Hospital Research Institute
Study Overview
Official Title:
Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented Distal Hypospadias Repair
Status:
COMPLETED
Status Verified Date:
2017-09
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:
None
Brief 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 1300 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
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
Detailed Description:
Males undergoing distal hypospadias repair involving stent placement were randomized to either receive or not to receive antibiotics post-operative All subjects did not receive intra-operative antibiotics Routine follow-up included having the stent removed one week post-op and a return visit at 3 months The research nurse made follow-up phone calls to the family or the PCP one week after the stent was removed and at one month post-op to see how things were going with the child and again after teh 3 month post surgical visit if the subject did not return after multiple rescheduling attempts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None