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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Experimental | trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days |
|
| Placebo | Placebo Comparator | placebo oral suspension, 0.5 mL/kg twice daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trimethoprim-sulfamethoxazole | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative infection | Urinary tract infection; cellulitis/wound infection | up to 30 days |
| wound-healing complications | meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| adverse drug reaction | up to 14 days | |
| C. difficile colitis | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Earl Y Cheng, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Mark A Faasse, MD, MPH | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| The Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144885 | Derived | Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 12, 2025 | |
| Reset | Mar 5, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2015 | Feb 11, 2022 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 12, 2025 | Mar 5, 2025 |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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|
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |