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Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction

NCT03685955 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-08-21

No results posted yet for this study

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)

Interventions

BIOLOGICAL

Amniotic membranes

Amniotic membranes will be employed during participant's genitourinary reconstruction

Sponsors & Collaborators

Principal Investigators

  • Heather DiCarlo, MD · The Johns Hopkins School of Medicine

Eligibility

Min Age
6 Months
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685955 on ClinicalTrials.gov