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.