Clinical trial NCT01832168: Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
Official title: A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pudendal Nerve
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 34
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to return of erectile function.
timeFrame: Up to 6 months
measure: Pain scores.
timeFrame: 10 days, 4 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson South Urology Center of Excellence
state: Florida
Study officials:
affiliation: Jackson South Urology Center of Excellence
name: Sanjay Razdan, MD
role: PRINCIPAL_INVESTIGATOR
References: