Use of the Amniotic Membrane in Large Wound Epithelialization

Wounds Clinical Trial

— MA/GH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824381
• Other study ID #: MA/GH
• Secondary ID: 2011-004395-11
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2013
• Last updated: March 29, 2017
• Start date: July 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Intervention

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.
• Obtaining and Cryopreservation of amniotic membrane

Drug:
• amniotic membrane

Locations

Country	Name	City	State
Spain	Clinical Universitary Hospital Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (6)

Lead Sponsor	Collaborator
Red de Terapia Celular	Consejería de Sanidad de la Comunidad Autónoma de la Región de Murcia, Facultad de Medicina. Universidad de Murcia., Fundación para la Formación e Investigación Sanitarias de la Región de Murcia, Hospital Universitario Virgen de la Arrixaca, MurciaSalud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	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.	3 years
Secondary	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.	1 year
Secondary	Changes in the signaling pathways of TGFb.	To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.	1 year

External Links

•   Fundación para la Formación e Investigación Sanitarias Región de Murcia
•   Official web of Health Service of Murcia Region.
•   Official web of Spanish Stem Cell Network