Back to resultsUse of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
Primary Purpose
External Hemorrhoid, External Hemorrhoid Thrombosed
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human dehydrated amnion chorion allograft
Sponsored by
About this trial
This is an interventional treatment trial for External Hemorrhoid
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Boulder Valley Surgical Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Human dehydrated amnion/chorion allofraft
Arm Description
Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft
Outcomes
Primary Outcome Measures
Reported Patient Pain
The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions
Do you experience pain continuously?
Do you experience pain with activity?
Do you experience pain while sitting?
Do you experience pain with bowel movements?
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479489
Brief Title
Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
Official Title
A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
External Hemorrhoid, External Hemorrhoid Thrombosed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human dehydrated amnion/chorion allofraft
Arm Type
Experimental
Arm Description
Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft
Intervention Type
Other
Intervention Name(s)
Human dehydrated amnion chorion allograft
Intervention Description
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
Primary Outcome Measure Information:
Title
Reported Patient Pain
Description
The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions
Do you experience pain continuously?
Do you experience pain with activity?
Do you experience pain while sitting?
Do you experience pain with bowel movements?
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Fetterolf, MD
Organizational Affiliation
MiMedx Group, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Boulder Valley Surgical Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
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