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

Primary Purpose

Wounds

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Place amniotic membrane in large wounds
Obtaining and Cryopreservation of amniotic membrane
amniotic membrane
Sponsored by
Red de Terapia Celular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds focused on measuring extensive wounds, amniotic membrane, healing, patients, phase granulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Universitary Hospital Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amniotic membrane in large wounds

Arm Description

Outcomes

Primary Outcome Measures

Safety
No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes.

Secondary Outcome Measures

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.
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.
Changes in the signaling pathways of TGFb.
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.

Full Information

First Posted
April 1, 2013
Last Updated
March 29, 2017
Sponsor
Red de Terapia Celular
Collaborators
Public Health Service, Murcia, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, MurciaSalud
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1. Study Identification

Unique Protocol Identification Number
NCT01824381
Brief Title
Use of the Amniotic Membrane in Large Wound Epithelialization
Acronym
MA/GH
Official Title
Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
Collaborators
Public Health Service, Murcia, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, MurciaSalud

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
extensive wounds, amniotic membrane, healing, patients, phase granulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amniotic membrane in large wounds
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Place amniotic membrane in large wounds
Intervention Description
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
Intervention Name(s)
Obtaining and Cryopreservation of amniotic membrane
Intervention Type
Drug
Intervention Name(s)
amniotic membrane
Primary Outcome Measure Information:
Title
Safety
Description
No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes.
Time Frame
Last revision at 3 years after surgery.
Secondary Outcome Measure Information:
Title
Measurement of the wound area
Description
To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.
Time Frame
3 years
Title
Evolution of local pain measured with a visual analog scale
Description
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.
Time Frame
1 year
Title
Changes in the signaling pathways of TGFb.
Description
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregorio Castellanos-Escrig, MD
Organizational Affiliation
Clinical Universitary Hospital Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Universitary Hospital Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.red-tercel.com
Description
Official web of Spanish Stem Cell Network
URL
http://www.ffis.es
Description
Fundación para la Formación e Investigación Sanitarias Región de Murcia
URL
http://www.murciasalud.es
Description
Official web of Health Service of Murcia Region.

Learn more about this trial

Use of the Amniotic Membrane in Large Wound Epithelialization

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