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NGS

DNA Sequencing vs Culture Testing for Infected Penile Implants

N/A

Recruiting

Research Sponsored by MicroGenDX

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Within 6 months of penile prosthesis surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will compare the effectiveness of next generation sequencing (NGS) versus standard culture for identifying microbes in clinically infected penile implants.

Who is the study for?

Men aged 18-80 who had penile prosthesis surgery within the last 6 months and are showing signs of infection like drainage, swelling, or exposed implant parts. It's not for those under 18 or over 80, with communication issues, non-compliance, active addiction, or if pain is their main concern.Check my eligibility

What is being tested?

This study compares traditional culture methods to next-generation DNA sequencing (NGS) in identifying infections in clinically infected penile implants to see which method affects patient outcomes better.See study design

What are the potential side effects?

Since this trial involves diagnostic methods rather than medications or invasive treatments, there are no direct side effects from the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have complications from a device, including skin issues or drainage.

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I had penile prosthesis surgery within the last 6 months.

Select...

I have a penile prosthesis.

Select...

I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Device survival rates by calculating by incidence of implant freely mobile and working without tenderness

Patient satisfaction of penile prosthesis

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group B - NGSExperimental Treatment1 Intervention

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

Group II: Group A - CultureActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MicroGenDXLead Sponsor

2 Previous Clinical Trials

135 Total Patients Enrolled

Media Library

Next-Generation DNA Sequencing (NGS) Clinical Trial Eligibility Overview. Trial Name: NCT05287438 — N/A

Infections Research Study Groups: Group B - NGS, Group A - Culture

Infections Clinical Trial 2023: Next-Generation DNA Sequencing Highlights & Side Effects. Trial Name: NCT05287438 — N/A

Next-Generation DNA Sequencing (NGS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287438 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up to partake in this trial?

"Yes, the information on clinicaltrials.gov clearly shows that this research is open for enrollment. Initially posted on October 27th 2021 and edited as recently as March 10th 2022, this trial requires 40 participants from 3 different medical centres."

Answered by AI

Is the age requirement for this study restricted to those under 45 years old?

"This medical trial is for adults aged 18 to 80. Those younger than the minimum age of consent have access to 199 clinical trials, whereas those over 65 can partake in 609 distinct studies."

Answered by AI

Who meets the eligibility criteria for entry in this research program?

"This medical trial seeks 40 individuals between 18 and 80 years of age who are currently infected. To qualify, the patient must have received a male penile prosthesis within six months prior to enrollment and demonstrate at least one of the following conditions: device part attachment resulting in thinning skin, drainage from wound site, swollen or exposed genitalia parts, draining open tract or hematoma."

Answered by AI

Are there still openings for participants in this experiment?

"The research study is currently seeking participants, with the original posting date on October 27th 2021 and a most recent update on March 10th 2022. This information can be found on clinicaltrials.gov."

Answered by AI

Recent research and studies

International Journal of Impotence ResearchJournal

Risk Factors Associated with Penile Prosthesis Infection: Systematic Review and Meta-analysis

Carvajal, Alejandro, Johana Benavides, Herney Andrés García-Perdomo, and Gerard D. Henry. 2020. “Risk Factors Associated with Penile Prosthesis Infection: Systematic Review and Meta-analysis”. International Journal of Impotence Research. Springer Science and Business Media LLC. doi:10.1038/s41443-020-0232-x.

Sexual Medicine ReviewsJournal

Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review

Mahon, Joseph, Ryan Dornbier, Grace Wegrzyn, Martha M. Faraday, Hossein Sadeghi-Nejad, Lawrence Hakim, and Kevin T. McVary. 2020. “Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review”. Sexual Medicine Reviews. Elsevier BV. doi:10.1016/j.sxmr.2019.07.005.

European Urology FocusJournal

Infection Prevention Strategies Prior to Penile Implant Surgery

Carrasquillo, Robert J., and Martin S. Gross. 2018. “Infection Prevention Strategies Prior to Penile Implant Surgery”. European Urology Focus. Elsevier BV. doi:10.1016/j.euf.2018.07.002.

Clinical Microbiology and InfectionJournal