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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01824381
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Public Health Service, Murcia
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
MurciaSalud
Information provided by (Responsible Party):
Red de Terapia Celular

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

Condition or disease Intervention/treatment Phase
Wounds Procedure: Place amniotic membrane in large wounds Procedure: Obtaining and Cryopreservation of amniotic membrane Drug: amniotic membrane Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
Study Start Date : July 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824381


Locations
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Spain
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Red de Terapia Celular
Public Health Service, Murcia
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
MurciaSalud
Investigators
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Principal Investigator: Gregorio Castellanos-Escrig, MD Clinical Universitary Hospital Virgen de la Arrixaca

Additional Information:
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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01824381    
Other Study ID Numbers: MA/GH
2011-004395-11 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Keywords provided by Red de Terapia Celular:
extensive wounds
amniotic membrane
healing
patients
phase granulation
Additional relevant MeSH terms:
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Wounds and Injuries