DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

Erectile Dysfunction Clinical Trial

Official title:

A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RALP) - Effect on Potency Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526173
• Other study ID #: AFRLP003
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: June 21, 2018

Study information

• Verified date: September 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.

Description:

The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to that of full nerve sparing RALP without dHACM application to neurovascular bundles.

Patients will be randomized to one of two possible treatment groups:

• Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®)

• Group 2 - Control Group ( Full Nerve Sparing RALP alone)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male subjects between the ages 40-70.

2. Primary diagnosis of prostate cancer requiring surgical intervention

3. Have a willingness to comply with follow-up examination

4. Have ability to provide full written consent

5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9

6. Planned elective radical prostatectomy with bilateral full nerve sparing technique

7. Patients who currently have a pre-operative SHIM > 19

8. Negative urinalysis within 7 days prior to date of surgery

Exclusion Criteria:

1. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced graft failure in the past

2. Has any condition(s), which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment

3. Has comorbid conditions that can be confused with or can exacerbate the condition, including diabetes or Advanced atherosclerotic vascular disease

4. Is unable to sign or understand informed consent

5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor

6. Has a history of drug or alcohol abuse within last 12 months

7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV

8. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)

9. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study

10. Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited

11. Has had prior hormonal therapy such as Lupron or oral anti-androgens

12. Living outside of United States

13. Partial nerve sparing technique used during Radical Prostatectomy

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• RALP using full nerve sparing technique
RALP using full nerve sparing technique

Other:
• dHACM Application
2x12 sheet of dHACM applied to the neurovascular bundle

Locations

Country	Name	City	State
United States	Florida Hospital: Global Robotics Institute	Celebration	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potency as assessed by Sexual Health Inventory for Men (SHIM) Score	As measured by SHIM	12 months
Primary	Return to sexual function	Patient directed questionnaire	12 months
Secondary	Continence	As assessed by American Urological Association (AUA) score	12 months
Secondary	Continence	Patient directed questionnaire	12 months