DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

NCT ID: NCT02526173

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2018-06-21

Brief 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.

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)

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dHACM

This group will receive RALP using full nerve sparing technique plus dHACM application.

Group Type: EXPERIMENTAL

RALP using full nerve sparing technique

Intervention Type: PROCEDURE

RALP using full nerve sparing technique

dHACM Application

Intervention Type: OTHER

2x12 sheet of dHACM applied to the neurovascular bundle

Control

This group will receive RALP using full nerve sparing technique only.

Group Type: OTHER

RALP using full nerve sparing technique

Intervention Type: PROCEDURE

RALP using full nerve sparing technique

Interventions

RALP using full nerve sparing technique

RALP using full nerve sparing technique

Intervention Type: PROCEDURE

dHACM Application

2x12 sheet of dHACM applied to the neurovascular bundle

Intervention Type: OTHER

Other Intervention Names

HCT/P Part 361

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vipul Patel, MD

Role: PRINCIPAL_INVESTIGATOR

MiMedx Group, Inc.

Locations

Florida Hospital: Global Robotics Institute

Celebration, Florida, United States

Countries

United States

Other Identifiers

AFRLP003

Identifier Type: -

Identifier Source: org_study_id