Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
NCT ID: NCT01832168
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2013-02-28
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.
Robotic Assisted Laparoscopic Prostatectomy
Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
Application of Absorbable Hemostat
Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.
AmnioFix
Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.
Robotic Assisted Laparoscopic Prostatectomy
Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
Application of dehydrated human amniotic membrane
Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.
Interventions
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Robotic Assisted Laparoscopic Prostatectomy
Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
70 Years
MALE
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjay Razdan, MD
Role: PRINCIPAL_INVESTIGATOR
Jackson South Urology Center of Excellence
Locations
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Jackson South Urology Center of Excellence
Miami, Florida, United States
Countries
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Other Identifiers
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AFRALP001
Identifier Type: -
Identifier Source: org_study_id
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