Status:
UNKNOWN
Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Lead Sponsor:
MicroGenDX
Conditions:
Penile Implantation
Infections
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.
Detailed Description
Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes. ...
Eligibility Criteria
Inclusion
- Male penile prosthesis patients
- Age range: 18-80
- Within 6 months of penile prosthesis surgery
- At least 1 of the following: Device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma
Exclusion
- Transgender / neophallus
- Not able to communicate or follow up well, or non-compliant
- Less than 18 or more than 80 years old
- Active addiction
- Main issue is implant pain
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05287438
Start Date
October 27 2021
End Date
October 31 2024
Last Update
March 18 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
WK Advanced Urology
Bossier City, Louisiana, United States, 71111
2
Duke University
Raleigh, North Carolina, United States, 27609
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107