Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|