NCT05196191

Wound Healing Following Penile Prosthesis Implant

Randomized Control Trial of Vivex Tissue for Accelerated Wound Healing Following Penile Prosthesis Placement With Follow-up

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: Male
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.

Detailed description

Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia. Even though it is not a part of normal aging, it is seen in 52% of men in the age group 40 to 70 years, with a higher rate in the men more than 70 years. VIAGENEX Max is a semi-transparent, collagenous membrane intended for soft tissue barrier or wound covering, derived from umbilical cord membrane. A total of 50 subjects with ED meeting the eligibility criteria will be randomized. The treatment graft will be placed into the wound at time of surgery. The treatment group will receive the VIAGENEX graft and the sham group will receive the standard of care for this surgery.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
BIOLOGICAL	VIAGENEX Max	Collagenous membrane derived from umbilical cord
PROCEDURE	Hibiclens wash	Antiseptic skin cleanser

Timeline

• Start date: 2022-01-03
• Primary completion: 2023-12-13
• Completion: 2023-12-30
• First posted: 2022-01-19
• Last updated: 2024-03-01

Locations

1 site across 1 country: United States