Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Hypospadias Clinical Trial

Official title:

Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593903
• Other study ID #: CHW 13/140
• Status: Completed
• Phase: N/A
• Start date: March 4, 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2018
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

Description:

The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (UTIs) and complications. However, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications. This is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. Subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 2 Years

Eligibility

Inclusion Criteria:

• all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair

• children of parents who give informed consent

• English speaking

• participant must be available for follow-up 3 and 12 months post-surgery

Exclusion Criteria:

• all proximal hypospadias and redo hypospadias repairs

• children who are allergic to sulfa medications

• patients who have UTI at time of surgery (proven by culture)

Related Conditions & MeSH terms

• Hypospadias

Intervention

Drug:
• Septra

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

Meir DB, Livne PM. Is prophylactic antimicrobial treatment necessary after hypospadias repair? J Urol. 2004 Jun;171(6 Pt 2):2621-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Urinary Tract Infection	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.	4-8 days post-operation