Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

Not Applicable

Completed

• Conditions: External Hemorrhoid Thrombosed; External Hemorrhoid
• Interventions: Other: Human dehydrated amnion chorion allograft

• Registration Number: NCT03479489
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-24
• Study First Posted: 2018-03-27
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human dehydrated amnion/chorion allofraft	Human dehydrated amnion chorion allograft	Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft

Primary Outcome Measures

Name	Time	Method
Reported Patient Pain	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?

Trial Locations

Locations (1)

Boulder Valley Surgical Associates; 🇺🇸 Boulder, Colorado, United States