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Trial record 34 of 119 for:    "Penile Disease"

Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

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ClinicalTrials.gov Identifier: NCT02593903
Recruitment Status : Completed
First Posted : November 2, 2015
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Travis Groth, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE October 30, 2015
First Posted Date  ICMJE November 2, 2015
Results First Submitted Date  ICMJE September 17, 2018
Results First Posted Date  ICMJE November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE March 4, 2014
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
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.
Change History Complete list of historical versions of study NCT02593903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair
Official Title  ICMJE Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypospadias
Intervention  ICMJE Drug: Septra
Other Names:
  • Bactrim
  • Sulfamethoxazole/trimethoprim
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Septra
  • No Intervention: No Antibiotics Group
    Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2018)
67
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2015)
160
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Months to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593903
Other Study ID Numbers  ICMJE CHW 13/140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Travis Groth, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Children's Hospital and Health System Foundation, Wisconsin
Investigators  ICMJE
Principal Investigator: Travis W Groth, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP