Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

External Hemorrhoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479489
• Other study ID #: EFSUR001
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2019
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• External Hemorrhoid
• External Hemorrhoid Thrombosed
• Hemorrhoids

Intervention

Other:
• Human dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft

Locations

Country	Name	City	State
United States	Boulder Valley Surgical Associates	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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