A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically localized prostate cancer with Gleason score 6 or 7
- •SHIM Score greater than or equal to 16 in the absence of medication
- •Feasibility to perform unilateral or bilateral nerve sparing RALP
Exclusion Criteria
- •Clinically locally advanced cancer and/or with Gleason score 8 or
- •Difficulty performing nerve sparing RALP.
- •Prior surgery at the site.
- •Site exhibits clinical signs and symptoms of infection.
- •SHIM score at screening <
- •Current use of anticoagulant medication including Coumadin, Plavix, etc.
- •Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
- •Has prior radiation therapy treatment at the site.
- •Prior hormonal therapy such as Lupron or oral anti-androgens.
- •Non-mobile, i.e. not ambulatory or bed ridden.
- •The presence of comorbidities that can be confused with or can exacerbate the condition including:
- •advanced atherosclerotic vascular disease
- •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.
- •Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- •Unable to comply with penile rehabilitation.
- •Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- •Patients who are unable to understand the aims and objectives of the trial.
- •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.
- •Currently taking medications which could affect graft incorporation (supervising physician's discretion).
- •Allergic to gentamicin and/or streptomycin.
- •Damage to neurovascular bundles during surgery.
Arms & Interventions
Control
Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.
Intervention: Robotic Assisted Laparoscopic Prostatectomy (Procedure)
Control
Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.
Intervention: Application of Absorbable Hemostat (Other)
AmnioFix
Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.
Intervention: Robotic Assisted Laparoscopic Prostatectomy (Procedure)
AmnioFix
Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.
Intervention: Application of dehydrated human amniotic membrane (Other)
Outcomes
Primary Outcomes
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
Time Frame: 4 weeks
Secondary Outcomes
- Time to return of erectile function.(Up to 6 months)
- Pain scores.(10 days, 4 weeks, 3 months, and 6 months)