Use of the Amniotic Membrane in Large Wound Epithelialization

Study Overview
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Brief Summary
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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.

Official Title
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Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.

Conditions
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Wounds

Intervention / Treatment
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* Procedure: Place amniotic membrane in large wounds
* Procedure: Obtaining and Cryopreservation of amniotic membrane
* Drug: amniotic membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute wounds in granulation phase with a minimum area of 100 cm2. Patients 18 or more years. Patients offering sufficient guarantees of adherence to protocol. Sign the written informed consent. Meet all 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: Complete abstinence from sexual intercourse Surgical sterilization (tubal ligation) Surgical sterilization of the partner (vasectomy) Implanted or injectable hormonal contraceptives, oral * Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control. These reliable contraception must be maintained during their participation in the study. Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test. Participation in other clinical trials. Inability to understand informed consent.

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 large wounds<br> | Procedure: Place amniotic membrane in large wounds<br>* 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.<br>Procedure: Obtaining and Cryopreservation of amniotic membrane<br> <br> Drug: amniotic membrane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase granulation, extensive wounds, amniotic membrane, healing, patients