Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

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
• 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