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

NCT ID: NCT01948934

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-02-06

Brief Summary

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

Detailed 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.

Conditions

Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

amniotic membrane in big wounds

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

Group Type: EXPERIMENTAL

Amniotic membrane in big wounds

Intervention Type: PROCEDURE

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

Interventions

Amniotic membrane in big wounds

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregorio Castellanos Escrig, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario Virgen de la Arrixca

Locations

Gregorio Castellanos Escrig MD

Murcia, El Palmar, Spain

Countries

Spain

Other Identifiers

2011-004395-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MA/GH

Identifier Type: -

Identifier Source: org_study_id