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

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 1

Conditions: Wounds

Treatments: Procedure: Obtaining and Cryopreservation of amniotic membrane; Procedure: Place amniotic membrane in large wounds; Drug: amniotic membrane

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01824381

MA/GH

2011-004395-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Amniotic membrane in large wounds

Experimental group

Treatment:

Procedure: Place amniotic membrane in large wounds

Drug: amniotic membrane

Procedure: Obtaining and Cryopreservation of amniotic membrane