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Antibiotic Use Following Distal and Mid-shaft 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. Identifier: NCT02593903
Recruitment Status : Completed
First Posted : November 1, 2015
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Travis Groth, Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Hypospadias Drug: Septra Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Septra
Other Names:
  • Bactrim
  • Sulfamethoxazole/trimethoprim

No Intervention: No Antibiotics Group
Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02593903

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
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Principal Investigator: Travis W Groth, MD Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Travis Groth, Medical College of Wisconsin:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Travis Groth, Assistant Professor, MD, Medical College of Wisconsin Identifier: NCT02593903    
Other Study ID Numbers: CHW 13/140
First Posted: November 1, 2015    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Travis Groth, Medical College of Wisconsin:
Antibiotic Prophylaxis
Additional relevant MeSH terms:
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Penile Diseases
Urogenital Abnormalities
Congenital Abnormalities
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents