Use of the Amniotic Membrane in Large Wound Epithelialization (MA/GH)
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|ClinicalTrials.gov Identifier: NCT01824381|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Procedure: Place amniotic membrane in large wounds Procedure: Obtaining and Cryopreservation of amniotic membrane Drug: amniotic membrane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
|Experimental: Amniotic membrane in large wounds||
Procedure: Place amniotic membrane in large wounds
After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed.
The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue.
We will place a new membrane weekly to a maximum of 6 times.
Procedure: Obtaining and Cryopreservation of amniotic membrane
Drug: amniotic membrane
- Safety [ Time Frame: Last revision at 3 years after surgery. ]
No serious adverse events possibly, probably or definitely related with the procedure.
No appearance of clinical inflammatory changes.
- Measurement of the wound area [ Time Frame: 3 years ]To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.
- Evolution of local pain measured with a visual analog scale [ Time Frame: 1 year ]To assess the effects of the application of amniotic membrane in the symptomatology of patients through the development of local pain measured with a visual analog scale.
- Changes in the signaling pathways of TGFb. [ Time Frame: 1 year ]To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.
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): NCT01824381
|Clinical Universitary Hospital Virgen de la Arrixaca|
|El Palmar, Murcia, Spain, 30120|
|Principal Investigator:||Gregorio Castellanos-Escrig, MD||Clinical Universitary Hospital Virgen de la Arrixaca|