Wound Healing Following Penile Prosthesis Implant

Sponsor

VIVEX Biologics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05196191

Collaborator

(none)

Enrollment

Location

Arms

15.8

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Biological: VIAGENEX Max Procedure: Hibiclens wash	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects meeting criteria will be randomized 4:1 treatment (Viagenex Max) or sham (standard of care).Subjects meeting criteria will be randomized 4:1 treatment (Viagenex Max) or sham (standard of care).

Masking:

Single (Participant)

Masking Description:

Subjects will not be told which treatment group they receive until the end of study participation.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Viagenex Max VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.	Biological: VIAGENEX Max Collagenous membrane derived from umbilical cord
Active Comparator: Standard of care Hibiclens wash will be performed.	Procedure: Hibiclens wash Antiseptic skin cleanser

Arm

Intervention/Treatment

Experimental: Viagenex Max

VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.

Biological: VIAGENEX Max

Collagenous membrane derived from umbilical cord

Active Comparator: Standard of care

Hibiclens wash will be performed.

Procedure: Hibiclens wash

Antiseptic skin cleanser

Outcome Measures

Primary Outcome Measures

Penile implant activation [up to 3 months]
Time to use implant for sexual activity

Secondary Outcome Measures

Pain after undergoing penile prosthesis surgery [surgery to 12 months]
Numerical pain scale (0=no pain to 10=worst pain) used to

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The patient must be willing and able to provide informed consent
The patient is a male between >/= 30 and =/< 70 years of age
The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
The patient has been in a stable relationship for over 3 months prior to enrollment
A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
The patient is suffering from erectile dysfunction and undergoing penile implant surgery for the first time
IIEF-EF score between 16 and 25
Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
A1C level </= 7% within 1 month prior to enrollment

Exclusion Criteria:

The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study
The patient is under judicial protection (prison or custody)
The patient is an adult under guardianship
The patient refuses to sign the consent
History of radical prostatectomy or extensive pelvic surgery
Evidence of venous leak
Past radiation therapy of the pelvic region within 12 months prior to enrollment
Recovering from any cancer within 12 months prior to enrollment
Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator
Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator
Anatomical malformation of the penis, including Peyronie's disease
Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
A1C level > 7% within 1 month prior to enrollment or history of insulin dependent diabetes
The patient is taking blood thinners and has an international normalized ratio >3
Received shockwave treatment at least 6 months before enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Cosmetic Urology	Atlanta	Georgia	United States	30305

Sponsors and Collaborators

VIVEX Biologics, Inc.

Investigators

Principal Investigator: Tariq Hakky, MD, Atlanta Cosmetic Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VIVEX Biologics, Inc.

ClinicalTrials.gov Identifier:

NCT05196191

Other Study ID Numbers:

CYG-2021-001

First Posted:

Jan 19, 2022

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VIVEX Biologics, Inc.

Viagenex Max

penile implant

erectile dysfunction

Additional relevant MeSH terms:

Erectile Dysfunction

Chlorhexidine gluconate

Study Results

No Results Posted as of Jan 19, 2022