Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

NCT03479489 | Completed

• 1 other identifier: EFSUR001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

External Hemorrhoid; External Hemorrhoid Thrombosed

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Human dehydrated amnion/chorion allofraft

EXPERIMENTAL

Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft

Other: Human dehydrated amnion chorion allograft

Interventions

Human dehydrated amnion chorion allograft OTHER

Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft

Human dehydrated amnion/chorion allofraft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Boulder Valley Surgical Associates

Boulder, Colorado, 80303, United States

Location

Study Officials

• Donald Fetterolf, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: February 5, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)