Overview

Use of the Amniotic Membrane in Large Wound Epithelialization

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Red de Terapia Celular
Collaborators:
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
Public Health Service, Murcia
Universidad de Murcia
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.