Erectile Dysfunction Clinical Trial
Official title:
A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RALP) - Effect on Potency Outcomes
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)
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