Infections, Penile Implantation
Conditions
Keywords
next generation sequencing, penile prosthesis, infections
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. Eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history/known allergies to antibiotics, symptom scoring questionnaire. Drainage swabs OR needle aspiration will be collected for standard culture and PCR/NGS and empiric antibiotics will start. Subjects will be randomized into the culture arm or the NGS arm. If randomized to NGS: central ID reviews result according to arm and offers recommendations. Physician will treat based on antibiotic recommendations (based on positive PCR/NGS or positive culture, if negative then empiric treatment will be continued) adjusted for patients contraindications and co-morbidities If randomized to the traditional culture arm: Physician will follow routine local standard of care. A follow-up visit will occur within 10 days of starting empiric antibiotic therapy to collect symptoms scoring questionnaire. A 2nd and final visit will occur 6 months after baseline to collect similar data to the 1st follow up visit.
Interventions
DIAGNOSTIC_TESTNext-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
DIAGNOSTIC_TESTStandard Culture
Standard of care culture and sensitivity
Sponsors
MicroGenDX
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Group A will receive results based on standard culture and Group B will receive results based on NGS
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device survival rates by calculating by incidence of implant freely mobile and working without tenderness | 2 years | To determine if device survival rates outcomes are improved using NGS versus traditional culture |
| Patient satisfaction of penile prosthesis | 2 years | Satisfaction is a 5-point descriptive scale in which subjects self-report that degree of satisfaction: high, mostly, fair, minimum, and none |
Countries
United States
Outcome results
None listed