CompletedNot Applicable

Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

United States11 participantsStarted 2018-02-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Reported Patient Pain

Timeframe: 60 days

Trial details

NCT IDNCT03479489

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More External Hemorrhoid trials