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DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

NCT02526173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-09-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Vipul Patel, MD · MiMedx Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2018-06-21
Completion
2018-06-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526173 on ClinicalTrials.gov