Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

Post Operative Recovery Clinical Trial

Official title: Radical Prostectomy (RAP): Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft

Status Withdrawn

Clinical Trial Summary

The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).

Clinical Trial Description

Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries. The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank. The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly. ;

Related Conditions & MeSH terms

• Post Operative Recovery

• NCT number: NCT05081232
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Withdrawn
• Phase: N/A
• Start date: January 2024
• Completion date: August 2024