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

March 24, 2017 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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
    • El Palmar
      • Murcia, El Palmar, Spain, 30120
        • Gregorio Castellanos Escrig MD

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

14 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 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

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 big wounds
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serious adverse events
Time Frame: 12 months
12 months
inflammatory changes
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound evaluation
Time Frame: 12 months
inflammatory condition of the wound,surface,
12 months
immunological evaluation
Time Frame: 12 months
anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection
12 months
histological evaluation
Time Frame: 12 months
Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy
12 months
microbiological evaluation
Time Frame: 12 months
microbiological culture
12 months

Collaborators and Investigators

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

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

  • Principal Investigator: Gregorio Castellanos Escrig, MD, Hospital Clinico Universitario Virgen de la Arrixca

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

June 1, 2012

Primary Completion (Actual)

February 6, 2017

Study Completion (Actual)

February 6, 2017

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 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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