Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

Pudendal Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832168
• Other study ID #: AFRALP001
• Status: Completed
• Phase: N/A
• First received: April 11, 2013
• Last updated: March 16, 2015
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pudendal Nerve

Intervention

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.
• Application of dehydrated human amniotic membrane
Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.

Locations

Country	Name	City	State
United States	Jackson South Urology Center of Excellence	Miami	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	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	No
Secondary	Time to return of erectile function.		Up to 6 months	No
Secondary	Pain scores.		10 days, 4 weeks, 3 months, and 6 months	No