Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

MiMedx

Status: Completed

Conditions: External Hemorrhoid; External Hemorrhoid Thrombosed

Treatments: Other: Human dehydrated amnion chorion allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT03479489

EFSUR001

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Human dehydrated amnion/chorion allofraft

Experimental group

Description:

Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft

Treatment:

Other: Human dehydrated amnion chorion allograft