Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction

NCT03685955 | Withdrawn FDA Drug

• 1 other identifier: IRB00168089
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypospadias; Hypospadias and Epispadias and Other Penile Anomalies; Fistula; Fistula, Urinary; Bladder Exstrophy and Epispadias Complex; Bladder and Bladder Neck Disorders (Excluding Calculi)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Genitourinary Reconstruction with Amniotic Membranes

Patients who undergo genitourinary reconstruction with amniotic membranes

Biological: Amniotic membranes

Interventions

Amniotic membranes BIOLOGICAL

Amniotic membranes will be employed during participant's genitourinary reconstruction

Genitourinary Reconstruction with Amniotic Membranes

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult populations with complex genitourinary reconstructive needs including pediatric hypospadias repair, bladder exstrophy, neurogenic bladder, urinary fistulas, urethral stricture disease

You may qualify if:

• mo - 99 years old
• Undergoing surgical procedure with risk of or known urinary fistula

You may not qualify if:

• Failed prior repair with amniotic membranes
• Sensitivity to cryopreservation fluids or disinfecting solutions.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (7)

• 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.

  PMID: 27489115 BACKGROUND

• 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.

  PMID: 27681807 BACKGROUND

• 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.

  PMID: 26401419 BACKGROUND

• 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.

  PMID: 25296347 BACKGROUND

• 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.

  PMID: 23279098 BACKGROUND

• 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.

  PMID: 29245303 BACKGROUND

• 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.

  PMID: 25048468 RESULT

MeSH Terms

Conditions

Hypospadias; Epispadias; Fistula; Urinary Fistula; Bladder Exstrophy and Epispadias Complex

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urethral Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather DiCarlo, MD

  The Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08