Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane

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.

Study Overview

• Status: Completed
• Conditions: External Hemorrhoid; External Hemorrhoid Thrombosed
• Intervention / Treatment: Other: Human dehydrated amnion chorion allograft

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Boulder Valley Surgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	60 days

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Study Director: Donald Fetterolf, MD, MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 24, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: EFSUR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No