Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
|ClinicalTrials.gov Identifier: NCT03479489|
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|External Hemorrhoid External Hemorrhoid Thrombosed||Other: Human dehydrated amnion chorion allograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Experimental: Human dehydrated amnion/chorion allofraft
Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft
Other: Human dehydrated amnion chorion allograft
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
- Reported Patient Pain [ Time Frame: 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?
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479489
|United States, Colorado|
|Boulder Valley Surgical Associates|
|Boulder, Colorado, United States, 80303|
|Study Director:||Donald Fetterolf, MD||MiMedx Group, Inc.|