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Wound Healing Protocols for Erectile Dysfunction Post-Surgery

N/A
Waitlist Available
Led By Tariq Hakky, MD
Research Sponsored by Vivex Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is undergoing penile implant surgery for the first time
The patient is a male between 30 and 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery to 12 months
Awards & highlights

Study Summary

This trial is testing two different treatment schedules for men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.

Who is the study for?
Men aged 30-70 with erectile dysfunction (ED), planning their first penile implant surgery, and in a stable relationship for over 3 months. They must have an IIEF-EF score of 16-25, at least two sexual attempts per month, normal testosterone levels (300-1000 ng/dL), and controlled blood sugar (A1C </=7%). Exclusions include recent participation in other studies, certain medical conditions like venous leak or pelvic radiation therapy within the last year, insulin-dependent diabetes with high A1C (>7%), or use of psychiatric medications affecting ED.Check my eligibility
What is being tested?
The trial is testing VIAGENEX Max treatment versus a Hibiclens wash regimen on wound healing after first-time penile prosthesis implantation. It's a prospective study where patients are randomly assigned to either active treatment or sham group in a ratio of 2:1.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the treatments applied to the surgical area. Since this trial focuses on post-surgical care rather than systemic medication, widespread side effects are less likely but can vary based on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having my first penile implant surgery.
Select...
I am a man aged between 30 and 70.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Penile implant activation
Secondary outcome measures
Pain after undergoing penile prosthesis surgery

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Viagenex MaxExperimental Treatment1 Intervention
VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.
Group II: Standard of careActive Control1 Intervention
Hibiclens wash will be performed.

Find a Location

Who is running the clinical trial?

Vivex Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
10,274 Total Patients Enrolled
VIVEX Biologics, Inc.Lead Sponsor
7 Previous Clinical Trials
10,774 Total Patients Enrolled
Tariq Hakky, MDPrincipal InvestigatorAtlanta Cosmetic Urology

Media Library

Hibiclens wash Clinical Trial Eligibility Overview. Trial Name: NCT05196191 — N/A
Erectile Dysfunction Research Study Groups: Viagenex Max, Standard of care
Erectile Dysfunction Clinical Trial 2023: Hibiclens wash Highlights & Side Effects. Trial Name: NCT05196191 — N/A
Hibiclens wash 2023 Treatment Timeline for Medical Study. Trial Name: NCT05196191 — N/A

Frequently Asked Questions

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

Are individuals aged 40 and over qualifying for this research study?

"Patients in this medical research project must be between 30 and 70 years of age."

Answered by AI

How many recruits are participating in this clinical experiment?

"Affirmative. Patient recruitment information on clinicaltrials.gov evidences that this medical trial, first posted on March 1st 2022, is currently seeking applicants. Specifically, 50 individuals must be found from a single research facility for admission into the study."

Answered by AI

Is there an opportunity for me to partake in this medical research?

"To be eligible for the trial, patients must present with erectile dysfunction and should fall between the ages of 30 and 70. The experiment is currently recruiting about 50 people."

Answered by AI

Is recruitment open for this research endeavor?

"Affirmative. The facts hosted on clinicaltrials.gov reveal that the trial, which was first posted in the beginning of March 2022, is currently recruiting participants. A total of 50 patients are needed from a solitary centre to participate."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Wound Healing Following Penile Prosthesis Implant
2022. "Wound Healing Following Penile Prosthesis Implant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05196191.
~10 spots leftby May 2025
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