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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dHACM | Experimental | This group will receive RALP using full nerve sparing technique plus dHACM application. |
|
| Control | Other | This group will receive RALP using full nerve sparing technique only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RALP using full nerve sparing technique | Procedure | RALP using full nerve sparing technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Potency as assessed by Sexual Health Inventory for Men (SHIM) Score | As measured by SHIM | 12 months |
| Return to sexual function | Patient directed questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Continence | As assessed by American Urological Association (AUA) score | 12 months |
| Continence | Patient directed questionnaire | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vipul Patel, MD | MiMedx Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital: Global Robotics Institute | Celebration | Florida | 34747 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| dHACM Application | Other | 2x12 sheet of dHACM applied to the neurovascular bundle |
|
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |