Recruiting

Next Generation Sequencing vs. Traditional Cultures

Sponsor:

MicroGenDX

Code:

NCT05287438

Conditions

Penile Implantation

Infections

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Next-Generation DNA Sequencing

Standard Culture

Study Details

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.

Conditions

Penile Implantation

Infections

Study ID

NCT05287438

Start date

Oct 27, 2021

Status verified date

Mar, 2022

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Group A - Culture

Following local standard of care, treatment will be based on standard culture

experimental: Group B - NGS

Treatment will be based on NGS results reviewed by an infectious disease doctor

Interventions

Next-Generation DNA Sequencing

NGS is a technique of microbiological sequencing, using 16s ribosomal RNA molecular identification has been implemented to detect bacteria and fungi present in the sample

Standard Culture

Standard of care culture and sensitivity

Primary outcome measure

  • Device survival rates by calculating by incidence of implant freely mobile and working without tenderness [ Time Frame: 2 years ]
  • Patient satisfaction of penile prosthesis [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

WK Advanced Urology

Recruiting

Bossier City, Louisiana, United States, 71111

Contacts

Ryan Griggs, MD

318-212-7335rpgriggsuro@gmail.com

Principal Investigator:

Gerard Henry, MD

Duke University

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Adi Molvin, RN, BSN

919-681-4990adi.molvin@dule.edu

Principal Investigator:

Aaron Lentz, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Paul Chung, MD

215-955-1000paul.chung@jefferson.edu

Principal Investigator:

Paul Chung, MD

More Information

Sponsor

MicroGenDX

Last update posted

Mar 18, 2022

Last verified

Mar, 2022

Keywords

  • next generation sequencing
  • penile prosthesis
  • infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MicroGenDX on 2022-03-18.