Use of the Amniotic Membrane in Large Wound Epithelialization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amniotic membrane in large wounds

Group Type EXPERIMENTAL

Place amniotic membrane in large wounds

Intervention Type 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.

Obtaining and Cryopreservation of amniotic membrane

Intervention Type PROCEDURE

amniotic membrane

Intervention Type DRUG

Interventions

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Place amniotic membrane in large wounds

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.

Intervention Type PROCEDURE

Obtaining and Cryopreservation of amniotic membrane

Intervention Type PROCEDURE

amniotic membrane

Intervention Type DRUG

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No