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

Phase 1

Completed

• Conditions: Wound
• Interventions: Procedure: Amniotic membrane in big wounds

• Registration Number: NCT01948934
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Primary Completion: 2017-02-06
• Study Completion: 2017-02-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
amniotic membrane in big wounds	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

Primary Outcome Measures

Name	Time	Method
inflammatory changes	12 months
serious adverse events	12 months

Secondary Outcome Measures

Name	Time	Method
wound evaluation	12 months	inflammatory condition of the wound,surface,
immunological evaluation	12 months	anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection
histological evaluation	12 months	Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy
microbiological evaluation	12 months	microbiological culture

Trial Locations

Locations (1)

Gregorio Castellanos Escrig MD; 🇪🇸 Murcia, El Palmar, Spain