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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004395-11 | EudraCT Number |
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The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds
Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amniotic membrane in big wounds | Experimental | The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic membrane in big wounds | Procedure | The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue |
| Measure | Description | Time Frame |
|---|---|---|
| serious adverse events | 12 months | |
| inflammatory changes | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| wound evaluation | inflammatory condition of the wound,surface, | 12 months |
| immunological evaluation | anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregorio Castellanos Escrig, MD | Hospital Clinico Universitario Virgen de la Arrixca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gregorio Castellanos Escrig MD | Murcia | El Palmar | 30120 | Spain |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 12 months |
| histological evaluation | Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy | 12 months |
| microbiological evaluation | microbiological culture | 12 months |