DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)
United States230 participantsStarted 2015-10-01
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male subjects between the ages 40-70.
✓. Primary diagnosis of prostate cancer requiring surgical intervention
✓. Have a willingness to comply with follow-up examination
✓. Have ability to provide full written consent
✓. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9
✓. Planned elective radical prostatectomy with bilateral full nerve sparing technique
✓. Patients who currently have a pre-operative SHIM \> 19
✓. Negative urinalysis within 7 days prior to date of surgery
Exclusion criteria
✕. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced graft failure in the past
✕. Has any condition(s), which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment
✕. Has comorbid conditions that can be confused with or can exacerbate the condition, including diabetes or Advanced atherosclerotic vascular disease
✕. Is unable to sign or understand informed consent
✕
What they're measuring
1
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score