Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

MiMedx

Status: Completed

Conditions: Pudendal Nerve

Treatments: Other: Application of dehydrated human amniotic membrane; Other: Application of Absorbable Hemostat; Procedure: Robotic Assisted Laparoscopic Prostatectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01832168

AFRALP001

Details and patient eligibility

About

The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.

Enrollment: 34 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages 45-70
2. Clinically localized prostate cancer with Gleason score 6 or 7
3. SHIM Score greater than or equal to 16 in the absence of medication
4. Feasibility to perform unilateral or bilateral nerve sparing RALP

Exclusion criteria

1. Clinically locally advanced cancer and/or with Gleason score 8 or 9.

2. Difficulty performing nerve sparing RALP.

3. Prior surgery at the site.

4. Site exhibits clinical signs and symptoms of infection.

5. SHIM score at screening <16.

6. Current use of anticoagulant medication including Coumadin, Plavix, etc.

7. Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.

8. Has prior radiation therapy treatment at the site.

9. Prior hormonal therapy such as Lupron or oral anti-androgens.

10. Non-mobile, i.e. not ambulatory or bed ridden.

11. The presence of comorbidities that can be confused with or can exacerbate the condition including:

    1. diabetes
    2. advanced atherosclerotic vascular disease

12. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.

13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.

14. Unable to comply with penile rehabilitation.

15. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

16. Patients who are unable to understand the aims and objectives of the trial.

17. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.

18. Currently taking medications which could affect graft incorporation (supervising physician's discretion).

19. Allergic to gentamicin and/or streptomycin.

20. Damage to neurovascular bundles during surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Control

Other group

Description:

Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.

Treatment:

Procedure: Robotic Assisted Laparoscopic Prostatectomy

Other: Application of Absorbable Hemostat

AmnioFix

Experimental group

Description:

Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.

Treatment:

Procedure: Robotic Assisted Laparoscopic Prostatectomy

Other: Application of dehydrated human amniotic membrane