Hypospadias
Conditions
Keywords
Antibiotic Prophylaxis
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.
Interventions
DRUGSeptra
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
6 Months to 2 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Tract Infection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| No Antibiotics Group Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. | 32 |
| Total | 67 |
Baseline characteristics
| Characteristic | Antibiotics Group | No Antibiotics Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 32 Participants | 67 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Male | 35 Participants | 32 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 32 |
| other Total, other adverse events | 0 / 35 | 0 / 32 |
| serious Total, serious adverse events | 0 / 35 | 0 / 32 |
Outcome results
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.
Time frame: 4-8 days post-operation
Population: Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antibiotics Group | Number of Participants With Urinary Tract Infection | Post Op Urine Sample obtained | 30 Participants |
| Antibiotics Group | Number of Participants With Urinary Tract Infection | clinical UTI | 0 Participants |
| No Antibiotics Group | Number of Participants With Urinary Tract Infection | Post Op Urine Sample obtained | 22 Participants |
| No Antibiotics Group | Number of Participants With Urinary Tract Infection | clinical UTI | 0 Participants |