Use of the Amniotic Membrane in Large Wound Epithelialization (MA/GH)

March 29, 2017 updated by: Red de Terapia Celular

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

The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Clinical Universitary Hospital Virgen de la Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amniotic membrane in large wounds
Procedure: 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.

Procedure: Obtaining and Cryopreservation of amniotic membrane
Drug: amniotic membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Last revision at 3 years after surgery.

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
Time Frame: 3 years
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
Time Frame: 1 year
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.
Time Frame: 1 year
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red de Terapia Celular

Collaborators

Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
MurciaSalud
Public Health Service, Murcia

Investigators

  • Principal Investigator: Gregorio Castellanos-Escrig, MD, Clinical Universitary Hospital Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA/GH
  • 2011-004395-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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