Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.

The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.

Study Overview

• Status: Completed
• Conditions: Pudendal Nerve
• Intervention / Treatment: Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of Absorbable Hemostat; Other: Application of dehydrated human amniotic membrane

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Jackson South Urology Center of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Ages 45-70
2. Clinically localized prostate cancer with Gleason score 6 or 7
3. SHIM Score greater than or equal to 16 in the absence of medication
4. Feasibility to perform unilateral or bilateral nerve sparing RALP

Exclusion Criteria:

1. Clinically locally advanced cancer and/or with Gleason score 8 or 9.
2. Difficulty performing nerve sparing RALP.
3. Prior surgery at the site.
4. Site exhibits clinical signs and symptoms of infection.
5. SHIM score at screening <16.
6. Current use of anticoagulant medication including Coumadin, Plavix, etc.
7. Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
8. Has prior radiation therapy treatment at the site.
9. Prior hormonal therapy such as Lupron or oral anti-androgens.
10. Non-mobile, i.e. not ambulatory or bed ridden.

11. The presence of comorbidities that can be confused with or can exacerbate the condition including:

    1. diabetes
    2. advanced atherosclerotic vascular disease
12. 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.
13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
14. Unable to comply with penile rehabilitation.
15. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
16. Patients who are unable to understand the aims and objectives of the trial.
17. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
18. Currently taking medications which could affect graft incorporation (supervising physician's discretion).
19. Allergic to gentamicin and/or streptomycin.
20. Damage to neurovascular bundles during surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control; Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.	Procedure: Robotic Assisted Laparoscopic Prostatectomy; Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique; Other: Application of Absorbable Hemostat; Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.; Other Names: Surgicel® SNoW
EXPERIMENTAL: AmnioFix; Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.	Procedure: Robotic Assisted Laparoscopic Prostatectomy; Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique; Other: Application of dehydrated human amniotic membrane; Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.; Other Names: AmnioFix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to return of erectile function.	Up to 6 months
Pain scores.	10 days, 4 weeks, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Sanjay Razdan, MD, Jackson South Urology Center of Excellence

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (ESTIMATE): April 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AFRALP001