The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to that of full nerve sparing RALP without dHACM application to neurovascular bundles. Patients will be randomized to one of two possible treatment groups: * Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®) * Group 2 - Control Group ( Full Nerve Sparing RALP alone)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
230
RALP using full nerve sparing technique
2x12 sheet of dHACM applied to the neurovascular bundle
Florida Hospital: Global Robotics Institute
Celebration, Florida, United States
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score
As measured by SHIM
Time frame: 12 months
Return to sexual function
Patient directed questionnaire
Time frame: 12 months
Continence
As assessed by American Urological Association (AUA) score
Time frame: 12 months
Continence
Patient directed questionnaire
Time frame: 12 months
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