Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

Not Applicable

Completed

• Conditions: Pudendal Nerve
• Interventions: Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of dehydrated human amniotic membrane; Other: Application of Absorbable Hemostat

• Registration Number: NCT01832168
• Lead Sponsor: MiMedx Group, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-15
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Robotic Assisted Laparoscopic Prostatectomy	Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.
AmnioFix	Robotic Assisted Laparoscopic Prostatectomy	Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.
AmnioFix	Application of dehydrated human amniotic membrane	Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.
Control	Application of Absorbable Hemostat	Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to return of erectile function.	Up to 6 months
Pain scores.	10 days, 4 weeks, 3 months, and 6 months

Trial Locations

Locations (1)

Jackson South Urology Center of Excellence; 🇺🇸 Miami, Florida, United States