Antibiotic Use in Distal Hypospadias Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03275519|
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypospadias||Other: Randomization to not receive prophylactic antibiotics after surgery. Other: Randomization to receive prophylactic antibiotics after surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Using the block randomization procedures, a subject was assigned to a study group by computer using the REDCap randomization module. Subjects were randomized to receive post operative antibiotics or to not receive any antibiotics postoperative.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair|
|Actual Study Start Date :||January 19, 2015|
|Actual Primary Completion Date :||February 17, 2017|
|Actual Study Completion Date :||April 19, 2017|
Active Comparator: Antibiotics prophylaxis cohort
Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.
Other: Randomization to receive prophylactic antibiotics after surgery
In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
Active Comparator: Antibiotic-sparing cohort
Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.
Other: Randomization to not receive prophylactic antibiotics after surgery.
No antibiotics were ordered after surgery.
- Prevalence of symptomatic UTI within 30 days post-surgery [ Time Frame: 30 days post surgery ]Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.
- Evaluation of surgical site infections (SSIs) and complications of hypospadias repair [ Time Frame: Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months ]Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.
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): NCT03275519
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Stephen Canon||Arkansas Children's Hospital, Pediatric Urology|