NCT05081232

Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Post Operative Recovery

Interventions

Type	Name	Description
DEVICE	MLG (Multi-Layered Perinatal Issue Allograft) Allograft	MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing. 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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2021-10-18
• Last updated: 2023-08-01

Regulatory

• FDA-regulated device study