NCT02526173

DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	RALP using full nerve sparing technique	RALP using full nerve sparing technique
OTHER	dHACM Application	2x12 sheet of dHACM applied to the neurovascular bundle

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-06-21
• Completion: 2018-06-21
• First posted: 2015-08-18
• Last updated: 2018-09-28

Locations

1 site across 1 country: United States