Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction

August 19, 2019 updated by: Johns Hopkins University

The Effect of Amniotic Membranes on Complex Genitourinary Reconstruction Outcomes in Pediatric and Adult Populations

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Urinary fistulas in the pediatric and adult populations present significant surgical and economical challenges. These include urethrocutaneous and vesicocutaneous fistulas, which are unfortunately common in the investigators' patients with hypospadias and bladder exstrophy, respectively. Urethrocutaneous fistula is the most common complication following surgical repair of hypospadias with an incidence of 4-25%. This high complication rate is especially problematic as these fistulas once formed often recur requiring multiple surgical repairs resulting in potentially harmful physical and psychologic consequences on young patients. Vesicocutaneous fistulas develop in bladder exstrophy patients at a estimated rate of 20% following surgery aimed at making these patients continent by transecting the bladder neck and creating a catheterizable channel. Small, simple fistulas can be repaired primarily, however larger, multiple or recurrent fistulas must be closed in layers. Layered closures have been found to have higher success rates have been demonstrated with using additional tissue layers refistulization rate including local and distant tissue grafts, which add time and morbidity to surgical repairs.

Amniotic membranes have been shown to increase healing in chronic wounds such as a chronic venous stasis and diabetic ulcers and have been used in fistula repairs. Grafix and Stravix are frozen preserved placental membranes and Wharton's Jelly, respectively, that have high quantities of viable mesenchymal stem cells (MSCs), which add in tissue healing. The investigators believe these membranes can be used as a structural layer in fistula repairs, hypospadias repairs, and bladder neck closures to treat existing fistulas and prevent fistula formation in the primary repair setting.

  1. This is a prospective study examining patients with hypospadias will be considered for repair with the use of amniotic membranes. The repair of fistula with graft tissue is standard of care.

  2. Eligible patients will be identified in a clinic visit with one of the co-investigators.

    a. The patient will be consented and undergo a repair using amniotic membranes within the fistula site or primary repair at the discretion of the operating surgeon. Using different repair techniques is standard of care, however, the use of frozen preserved placental membranes is the study material. The size of the product will be determined by the surgical need at the time of repair.

  3. The patient will be discharged be provided with routine postoperative care and seen in approximately 2 weeks per standard of are.
  4. If the participant fails repair of participant's fistula, participant will not be offered a repeat repair with the amniotic membranes. Other forms of surgery may be offered, however.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 6mo - 99 years old
  • Undergoing surgical procedure with risk of or known urinary fistula

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Genitourinary Reconstruction with Amniotic Membranes
Patients who undergo genitourinary reconstruction with amniotic membranes
Biological: Amniotic membranes
Amniotic membranes will be employed during participant's genitourinary reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate of complex genitourinary reconstruction after incorporation of placental membranes into repair.
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Heather DiCarlo, MD, The Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (ACTUAL)

September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00168089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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