Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

Completed · Not applicable

Conditions studied: External Hemorrhoid, External Hemorrhoid Thrombosed

In brief

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.

Key facts

Study ID: NCT03479489
Run by: MiMedx Group, Inc.
People needed: 11
Starts: 2018-02-05
Expected to finish: 2018-12-30
Last updated by the study team: 2019-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Boulder Valley Surgical Associates — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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