Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds

Conditions
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Wound

Intervention / Treatment
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* Procedure: Amniotic membrane in big wounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute wounds in granulation phase with a minimum surface of 100cm2 ≥ 18 years signing informed consent form guarantee adherence to protocol Exclusion Criteria: chronic arterial insufficiency pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method involved in other assay previous disease; kidney, heart, hepatic, systemic or immune inability to understand informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amniotic membrane in big wounds<br>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 | Procedure: Amniotic membrane in big wounds<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious adverse events |  | 12 months | 
| inflammatory changes |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, Injury, Membrane amniotic, Wound