External Hemorrhoid, External Hemorrhoid Thrombosed
Conditions
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.
Interventions
OTHERHuman dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
Sponsors
MiMedx Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Countries
United States
Outcome results
None listed