DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Procedure: RALP using full nerve sparing technique; Other: dHACM Application

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital: Global Robotics Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dHACM; This group will receive RALP using full nerve sparing technique plus dHACM application.	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; Other Names: HCT/P Part 361
Other: Control; This group will receive RALP using full nerve sparing technique only.	Procedure: RALP using full nerve sparing technique; RALP using full nerve sparing technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score	As measured by SHIM	12 months
Return to sexual function	Patient directed questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continence	As assessed by American Urological Association (AUA) score	12 months
Continence	Patient directed questionnaire	12 months

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Vipul Patel, MD, MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: AFRLP003