Last updated on September 2018

DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

Brief description of study

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.

Detailed Study Description

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)

Clinical Study Identifier: NCT02526173

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Tadzia Harvey Thurn, RN

Florida Hospital: Global Robotics Institute
Celebration, FL United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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