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NCT02593903
Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?
NA trial testing Septra in Hypospadias in 67 participants. Completed in 1 April 2018.
30 June 2017
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 4 March 2014 |
| Primary completion | 30 June 2017 |
| Estimated completion | 1 April 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Septra — full drug profile →
Conditions studied
- Hypospadias — all drugs for Hypospadias →
Sponsor
Medical College of Wisconsin
Who can join
Adults 6 Months to 2, male only, with Hypospadias. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study.
Roth EB, Kryger JV, Durkee CT, Lingongo MA, et al · · 2018 · cited 11× · PMID 29780414 · DOI 10.1155/2018/7031906
Verify or expand the search:
- PubMed search for NCT02593903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypospadias
Currently open trials in the same condition.
- NCT07426731 — Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery · NA · recruiting
- NCT07319780 — Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias · NA · recruiting
- NCT07017842 — PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landm · recruiting
- NCT06832280 — Improving Parental Support in Hypospadias Care · NA · recruiting
- NCT06520423 — Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias · NA · active not recruiting
Other Medical College of Wisconsin trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02593903 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
- Last refreshed: 2 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02593903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing