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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004395-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Public Health Service, Murcia | OTHER |
| Universidad de Murcia | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| MurciaSalud |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic membrane in large wounds | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Place amniotic membrane in large wounds | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes. | Last revision at 3 years after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the wound area | To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area. | 3 years |
| Evolution of local pain measured with a visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
Patients with symptomatic chronic arterial insufficiency.
Patients who are pregnant
Patients in active lactation
Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
These reliable contraception must be maintained during their participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Gregorio Castellanos-Escrig, MD | Clinical Universitary Hospital Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Universitary Hospital Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| Label | URL |
|---|---|
| Official web of Spanish Stem Cell Network | View source |
| Fundación para la Formación e Investigación Sanitarias Región de Murcia | View source |
| Official web of Health Service of Murcia Region. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001684 | Biological Dressings |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| OTHER_GOV |
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|
| Obtaining and Cryopreservation of amniotic membrane | Procedure |
|
| amniotic membrane | Drug |
|
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.
| 1 year |
| Changes in the signaling pathways of TGFb. | To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane. | 1 year |