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Trial record 34 of 119 for:    "Penile Disease"

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.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Hypospadias
Intervention Drug: Septra
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antibiotics Group No Antibiotics Group
Hide Arm/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. Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
Period Title: Overall Study
Started 35 32
Completed 35 31
Not Completed 0 1
Arm/Group Title Antibiotics Group No Antibiotics Group Total
Hide Arm/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. Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. Total of all reporting groups
Overall Number of Baseline Participants 35 32 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
<=18 years
35
 100.0%
32
 100.0%
67
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 35 participants 32 participants 67 participants
35
 100.0%
32
 100.0%
67
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants With Urinary Tract Infection
Hide Description 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.
Time Frame 4-8 days post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample
Arm/Group Title Antibiotics Group No Antibiotics Group
Hide Arm/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.
Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
Overall Number of Participants Analyzed 30 22
Measure Type: Count of Participants
Unit of Measure: Participants
Post Op Urine Sample obtained
30
 100.0%
22
 100.0%
clinical UTI
0
   0.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antibiotics Group No Antibiotics Group
Hide Arm/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. Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.
All-Cause Mortality
Antibiotics Group No Antibiotics Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Antibiotics Group No Antibiotics Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Antibiotics Group No Antibiotics Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Clinical Research Coordinator
Organization: Medical College of Wisconsin
Phone: 414-337-3441
Responsible Party: Travis Groth, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02593903     History of Changes
Other Study ID Numbers: CHW 13/140
First Submitted: October 30, 2015
First Posted: November 2, 2015
Results First Submitted: September 17, 2018
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018