Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
NCT Number: NCT01824381
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
El Palmar, Murcia, 30120, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
These reliable contraception must be maintained during their participation in the study.
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.
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.
Time frame: 3 years
To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.
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.
Time frame: 1 year
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.
Red de Terapia Celular
Industry
Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
Acronym: MA/GH
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