Antibiotic Use in Distal Hypospadias Repair

NCT03275519 | Completed

• 1 other identifier: IRB# 203532
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypospadias

Keywords

distal hypospadias repair; urinary tract infection; prophylactic antibiotic use

Outcome Measures

Primary Outcomes (1)

• Prevalence of symptomatic UTI within 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.

  30 days post surgery

Secondary Outcomes (1)

• Evaluation of surgical site infections (SSIs) and complications of hypospadias repair

  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

Study Arms (2)

Antibiotics prophylaxis cohort

ACTIVE COMPARATOR

Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.

Other: Randomization to receive prophylactic antibiotics after surgery

Antibiotic-sparing cohort

ACTIVE COMPARATOR

Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.

Other: Randomization to not receive prophylactic antibiotics after surgery.

Interventions

Randomization to not receive prophylactic antibiotics after surgery. OTHER

No antibiotics were ordered after surgery.

Antibiotic-sparing cohort

Randomization to receive prophylactic antibiotics after surgery OTHER

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.

Antibiotics prophylaxis cohort

Eligibility Criteria

• Age: 3 Months - 6 Years
• Gender Eligibility Details: Males undergoing hypospadias repair on their penis.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males undergoing primary distal hypospadias repair with open urethral stent drainage.

You may not qualify if:

• Males undergoing fistula repair or glandular hypospadias repair without incontinent urethral stent drainage and hypospadias repair of mid or more proximal degrees of hypospadias were excluded from this study.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Hypospadias; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Urologic Diseases

Study Officials

• Stephen Canon

  Arkansas Children's Hospital, Pediatric Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: September 7, 2017
• Study Start: January 19, 2015
• Primary Completion: February 17, 2017
• Study Completion: April 19, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)