Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
NCT ID: NCT03479489
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2018-02-05
2018-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Human dehydrated amnion/chorion allofraft
Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft
Human dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
Interventions
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Human dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
Eligibility Criteria
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Inclusion Criteria
2. Subject is undergoing closed hemorrhoidectomy as their definitive treatment for the Grade 2-4 hemorrhoid
3. Subject is age 18 or older
4. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Exclusion Criteria
2. Subject has signs and symptoms of active cirrhosis
3. Subject has signs and symptoms of Crohn's disease complicated by perianal manifestations
4. Subject is currently taking immunosuppressive medications
5. Subject has had previous surgery in the target area within the past 6 months prior to treatment or plans to have surgery other than closed hemorrhoidectomy in the target area within 180 days of treatment
6. Subject is currently receiving radiation therapy or chemotherapy
7. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
8. Subject is pregnant at enrollment or is planning to become pregnant within 180 days of treatment; subject intends to breastfeed during the course of the trial
9. Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
10. Subject has an allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Fetterolf, MD
Role: STUDY_DIRECTOR
MiMedx Group, Inc.
Locations
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Boulder Valley Surgical Associates
Boulder, Colorado, United States
Countries
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Other Identifiers
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EFSUR001
Identifier Type: -
Identifier Source: org_study_id