Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase: Completed; Phase 1

Conditions: Wound

Treatments: Procedure: Amniotic membrane in big wounds

Study type: Interventional

Funder types: Other

Identifiers

NCT01948934

MA/GH

2011-004395-11 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds

Full description

Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute wounds in granulation phase with a minimum surface of 100cm2
• ≥ 18 years
• signing informed consent form
• guarantee adherence to protocol

Exclusion criteria

• chronic arterial insufficiency
• pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
• involved in other assay
• previous disease; kidney, heart, hepatic, systemic or immune
• inability to understand informed consent form

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 big wounds

Experimental group

Description:

The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue

Treatment:

Procedure: Amniotic membrane in big wounds