Continence and Potency Following Multi-Layer Perinatal Issue alloGraft
NCT ID: NCT05081232
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-01-31
2024-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Umbilical Cord Allograft Recipients
Male patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
3. Primary diagnosis of organ confined untreated prostate cancer
4. Planned elective radical prostatectomy with bilateral nerve sparing technique
5. Negative urinalysis within 30 days prior to date of surgery
6. Patient has no erectile dysfunction (SHIM Score \< 14 ) prior to date of surgery
7. Patient has the willingness to comply with instruction of the investigator
8. Patient has the willingness to comply with follow-up surveys
9. Have ability to provide full written consent.
Exclusion Criteria
2. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
3. 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
4. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
5. Patients with poor urinary control at baseline requiring the use of pads for leakage
6. Previous history of pelvic radiation
7. Previous history of simple prostatectomy or transurethral prostate surgery
8. Patients with obesity defined as BMI \> 40 kg/m2
9. History of open pelvic surgery within 5 years except for hernia repair
10. Poorly controlled diabetes (A1C \>8.5%)
11. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
12. Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
13. Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
14. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
15. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
16. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
30 Years
65 Years
MALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Ram A Pathak, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Urology
References
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Neumaier MF, Segall CH Junior, Hisano M, Rocha FET, Arap S, Arap MA. Factors affecting urinary continence and sexual potency recovery after robotic-assisted radical prostatectomy. Int Braz J Urol. 2019 Jul-Aug;45(4):703-712. doi: 10.1590/S1677-5538.IBJU.2018.0704.
Carlsson S, Drevin L, Loeb S, Widmark A, Lissbrant IF, Robinson D, Johansson E, Stattin P, Fransson P. Population-based study of long-term functional outcomes after prostate cancer treatment. BJU Int. 2016 Jun;117(6B):E36-45. doi: 10.1111/bju.13179. Epub 2015 Jun 23.
Nelson CJ, Scardino PT, Eastham JA, Mulhall JP. Back to baseline: erectile function recovery after radical prostatectomy from the patients' perspective. J Sex Med. 2013 Jun;10(6):1636-43. doi: 10.1111/jsm.12135. Epub 2013 Apr 3.
Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.
Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
Castiglione F, Ralph DJ, Muneer A. Surgical Techniques for Managing Post-prostatectomy Erectile Dysfunction. Curr Urol Rep. 2017 Sep 30;18(11):90. doi: 10.1007/s11934-017-0735-2.
Menon M, Kaul S, Bhandari A, Shrivastava A, Tewari A, Hemal A. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. J Urol. 2005 Dec;174(6):2291-6, discussion 2296. doi: 10.1097/01.ju.0000181825.54480.eb.
Finley DS, Osann K, Skarecky D, Ahlering TE. Hypothermic nerve-sparing radical prostatectomy: rationale, feasibility, and effect on early continence. Urology. 2009 Apr;73(4):691-6. doi: 10.1016/j.urology.2008.09.085. Epub 2009 Feb 28.
Ogaya-Pinies G, Palayapalam-Ganapathi H, Rogers T, Hernandez-Cardona E, Rocco B, Coelho RF, Jenson C, Patel VR. Can dehydrated human amnion/chorion membrane accelerate the return to potency after a nerve-sparing robotic-assisted radical prostatectomy? Propensity score-matched analysis. J Robot Surg. 2018 Jun;12(2):235-243. doi: 10.1007/s11701-017-0719-8. Epub 2017 Jun 27.
Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.
Barski D, Gerullis H, Ecke T, Boros M, Brune J, Beutner U, Tsaur I, Ramon A, Otto T. Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol. Adv Ther. 2020 Jan;37(1):592-602. doi: 10.1007/s12325-019-01158-3. Epub 2019 Nov 28.
Razdan S, Bajpai RR, Razdan S, Sanchez MA. A matched and controlled longitudinal cohort study of dehydrated human amniotic membrane allograft sheet used as a wraparound nerve bundles in robotic-assisted laparoscopic radical prostatectomy: a puissant adjunct for enhanced potency outcomes. J Robot Surg. 2019 Jun;13(3):475-481. doi: 10.1007/s11701-018-0873-7. Epub 2018 Sep 12.
Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.
Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.
Bullard JD, Lei J, Lim JJ, Massee M, Fallon AM, Koob TJ. Evaluation of dehydrated human umbilical cord biological properties for wound care and soft tissue healing. J Biomed Mater Res B Appl Biomater. 2019 May;107(4):1035-1046. doi: 10.1002/jbm.b.34196. Epub 2018 Sep 10.
Other Identifiers
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IRB00076844
Identifier Type: -
Identifier Source: org_study_id
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