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Clinical Trial Summary

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.


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02526173
Study type Interventional
Source MiMedx Group, Inc.
Contact
Status Completed
Phase N/A
Start date October 1, 2015
Completion date June 21, 2018

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