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Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

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ClinicalTrials.gov Identifier: NCT03479489
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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.

Condition or disease Intervention/treatment Phase
External Hemorrhoid External Hemorrhoid Thrombosed Other: Human dehydrated amnion chorion allograft Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Human dehydrated amnion/chorion allofraft
Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft
Other: Human dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft




Primary Outcome Measures :
  1. Reported Patient Pain [ Time Frame: 60 days ]

    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?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of acutely thrombosed hemorrhoid or an external hemorrhoid exceeding 72 hours in duration
  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:

  1. Subject has a known history of poor compliance with medical treatments
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479489


Locations
United States, Colorado
Boulder Valley Surgical Associates
Boulder, Colorado, United States, 80303
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Study Director: Donald Fetterolf, MD MiMedx Group, Inc.

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT03479489     History of Changes
Other Study ID Numbers: EFSUR001
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhoids
Thrombosis
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis