Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair
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|ClinicalTrials.gov Identifier: NCT02593903|
Recruitment Status : Completed
First Posted : November 1, 2015
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypospadias||Drug: Septra||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?|
|Actual Study Start Date :||March 4, 2014|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||April 2018|
Experimental: Antibiotics Group
Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
No Intervention: No Antibiotics Group
Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
- Number of Participants With Urinary Tract Infection [ Time Frame: 4-8 days post-operation ]Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever >38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593903
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Travis W Groth, MD||Medical College of Wisconsin|