HypospadiasNCT03685955
Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction
An observational study of Hypospadias and Hypospadias and Epispadias and Other Penile Anomalies, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Hypospadias, Hypospadias and Epispadias and Other Penile Anomalies, Fistula
- What is being tested?
- Amniotic membranes
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult populations with complex genitourinary reconstructive needs including pediatric hypospadias repair, bladder exstrophy, neurogenic bladder, urinary fistulas, urethral stricture disease
Who may be able to join
- 6mo - 99 years old
- Undergoing surgical procedure with risk of or known urinary fistula
Who cannot join
- Failed prior repair with amniotic membranes
- Sensitivity to cryopreservation fluids or disinfecting solutions.
About this study
Official title: 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.
Read the 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.
- 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.
- Eligible patients will be identified in a clinic visit with one of the co-investigators.
- 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.
- The patient will be discharged be provided with routine postoperative care and seen in approximately 2 weeks per standard of are.
- 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.
- Conditions
- Hypospadias, Hypospadias and Epispadias and Other Penile Anomalies, Fistula, Fistula, Urinary, Bladder Exstrophy and Epispadias Complex, Bladder and Bladder Neck Disorders (Excluding Calculi)
- Being tested
- Amniotic membranes
- Medical subject headings
- Hypospadias, Epispadias, Fistula, Urinary Fistula, Bladder Exstrophy and Epispadias Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membranesBiological
Amniotic membranes will be employed during participant's genitourinary reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Genitourinary Reconstruction with Amniotic Membranes | Patients who undergo genitourinary reconstruction with amniotic membranes Receives: Biological: Amniotic membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Lack of supporting staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather DiCarlo, MD, Principal investigator, The Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685955
- Sponsor's protocol ID
- IRB00168089
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27489115Suzuki 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.
PubMed 27681807Duan-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.
PubMed 26401419Cooke 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.
PubMed 25296347Batsali 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.
PubMed 23279098Johnson 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.
PubMed 29245303Lavery 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.
PubMed 25048468
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amniotic Membranes on Complex Genitourinary Reconstruction Outcomes in Pediatric and Adult Populations
- ClinicalTrials.gov ID
- NCT03685955
- Acronym / sponsor ID
- IRB00168089
- Conditions
- Hypospadias, Hypospadias and Epispadias and Other Penile Anomalies, Fistula, Fistula, Urinary, Bladder Exstrophy and Epispadias Complex, Bladder and Bladder Neck Disorders (Excluding Calculi)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of supporting staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- Eligible patients will be identified in a clinic visit with one of the co-investigators.
- 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.
- The patient will be discharged be provided with routine postoperative care and seen in approximately 2 weeks per standard of are.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genitourinary Reconstruction with Amniotic Membranes | – | Biological: Amniotic membranesPatients who undergo genitourinary reconstruction with amniotic membranes |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult populations with complex genitourinary reconstructive needs including pediatric hypospadias repair, bladder exstrophy, neurogenic bladder, urinary fistulas, urethral stricture disease
Key inclusion criteria (2 listed)
- 6mo - 99 years old
- Undergoing surgical procedure with risk of or known urinary fistula
Key exclusion criteria (2 listed)
- Failed prior repair with amniotic membranes
- Sensitivity to cryopreservation fluids or disinfecting solutions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic membranesAmniotic membranes will be employed during participant's genitourinary reconstruction | Biological | Genitourinary Reconstruction with Amniotic Membranes |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 27489115Frykberg 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.
- Background: PubMed 27681807Suzuki 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.
- Background: PubMed 26401419Duan-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.
- Background: PubMed 25296347Cooke 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.
- Background: PubMed 23279098Batsali 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.
- Background: PubMed 29245303Johnson 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.
- Results publication: PubMed 25048468Lavery 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather DiCarlo, MD principal investigator
The Johns Hopkins School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadias and Hypospadias and Epispadias and Other Penile Anomalies, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate of complex genitourinary reconstruction after incorporation of placental membranes into repair. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685955, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.