Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes

Status unconfirmed · Not applicable

Conditions studied: Penile Implantation, Infections

In brief

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.

Key facts

Study ID

NCT05287438

Run by

MicroGenDX

People needed

40

Starts

2021-10-27

Expected to finish

2024-10-31

Last updated by the study team

2022-03-18

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• WK Advanced Urology — Bossier City, Louisiana, United States (enrolling)
• Duke University — Raleigh, North Carolina, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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