Sponsor study identifier
observational
0
0 countries
N/A
Study Start
March 2020
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Primary Completion
March 2021
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Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Urinary fistulas are unfortunately one of the most common post operative complications in hypospadias repairs and bladder neck transections on pediatric and adult populations, an estimated 20%, resulting in multiple repeat operations with prolonged hospitalization. The negative sequelae of these fistulas have significant financial and psychosocial impact and the aim of this study is to evaluate if the fresh frozen preserved amniotic membrane tissue studied, which have live cells and intact naturally occurring growth hormones and peptides that augment healing that have been shown in early studies to be effective facilitating previous failed fistula repairs and leg ulcer healing, respectively, will help reduce the incidence of urinary fistulas in subject populations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2018
Actual (reported)September 26, 2018
Actual (reported)March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Failure rate of complex genitourinary reconstruction after incorporation of placental membranes into repair.
We will evaluate patients with complex genitourinary wounds who have undergone surgical repair using preserved placental membranes, Grafix or Stravix. They will be evaluated in the standard post operative fashion to evaluate for failure of surgical repair of complex genitourinary reconstruction which will be defined by stricture recurrence, wound dehiscence, or recurrence of fistula.
2 years
Patients who undergo genitourinary reconstruction with amniotic membranes
Amniotic membranes will be employed during participant's genitourinary reconstruction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pediatric and adult populations with complex genitourinary reconstructive needs including pediatric hypospadias repair, bladder exstrophy, neurogenic bladder, urinary fistulas, urethral stricture disease
Frykberg RG, Gibbons GW, Walters JL, Wukich DK, Milstein FC. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. Int Wound J. 2017 Jun;14(3):569-577. doi: 10.1111/iwj.12649. Epub 2016 Aug 3.
Suzuki K, Michael G, Tamire Y. Viable intact cryopreserved human placental membrane for a non-surgical approach to closure in complex wounds. J Wound Care. 2016 Oct 1;25(Sup10):S25-S31. doi: 10.12968/jowc.2016.25.Sup10.S25.
Heather DiCarlo, MD
The Johns Hopkins School of Medicine
0 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2018
First Posted
September 26, 2018
Study Start
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assessment of Postop Hypospadias Pain
Contact the study team to confirm eligibility.
Duan-Arnold Y, Gyurdieva A, Johnson A, Uveges TE, Jacobstein DA, Danilkovitch A. Retention of Endogenous Viable Cells Enhances the Anti-Inflammatory Activity of Cryopreserved Amnion. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):523-533. doi: 10.1089/wound.2015.0636.
Cooke M, Tan EK, Mandrycky C, He H, O'Connell J, Tseng SC. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014 Oct;23(10):465-74, 476. doi: 10.12968/jowc.2014.23.10.465.
Batsali AK, Kastrinaki MC, Papadaki HA, Pontikoglou C. Mesenchymal stem cells derived from Wharton's Jelly of the umbilical cord: biological properties and emerging clinical applications. Curr Stem Cell Res Ther. 2013 Mar;8(2):144-55. doi: 10.2174/1574888x11308020005.
Johnson EL, Tassis EK, Michael GM, Whittinghill SG. Viable placental allograft as a biological dressing in the clinical management of full-thickness thermal occupational burns: Two case reports. Medicine (Baltimore). 2017 Dec;96(49):e9045. doi: 10.1097/MD.0000000000009045.
Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H, Owings TM, Nadarajah J; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix((R)) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014 Oct;11(5):554-60. doi: 10.1111/iwj.12329. Epub 2014 Jul 21.
Primary Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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