Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Medical College of Wisconsin

Status: Completed

Conditions: Hypospadias

Treatments: Drug: Septra

Study type: Interventional

Funder types: Other

Identifiers

NCT02593903

CHW 13/140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Male

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Antibiotics Group

Experimental group

Description:

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.

Treatment:

Drug: Septra

No Antibiotics Group

No Intervention group

Description:

Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.