Status:
COMPLETED
Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
External Hemorrhoid
External Hemorrhoid Thrombosed
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of acutely thrombosed hemorrhoid or an external hemorrhoid exceeding 72 hours in duration
- Subject is undergoing closed hemorrhoidectomy as their definitive treatment for the Grade 2-4 hemorrhoid
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Exclusion
- Subject has a known history of poor compliance with medical treatments
- Subject has signs and symptoms of active cirrhosis
- Subject has signs and symptoms of Crohn's disease complicated by perianal manifestations
- Subject is currently taking immunosuppressive medications
- 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
- Subject is currently receiving radiation therapy or chemotherapy
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- 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
- Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject has an allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03479489
Start Date
February 5 2018
End Date
December 30 2018
Last Update
December 18 2019
Active Locations (1)
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1
Boulder Valley Surgical Associates
Boulder, Colorado, United States, 80303