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

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948934
• Other study ID #: MA/GH
• Secondary ID: 2011-004395-11
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2013
• Last updated: March 24, 2017
• Start date: June 2012
• Est. completion date: February 6, 2017

Study information

• Verified date: March 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 6, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound
• Wounds and Injuries

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Gregorio Castellanos Escrig MD	Murcia	El Palmar

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serious adverse events		12 months
Primary	inflammatory changes		12 months
Secondary	wound evaluation	inflammatory condition of the wound,surface,	12 months
Secondary	immunological evaluation	anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection	12 months
Secondary	histological evaluation	Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy	12 months
Secondary	microbiological evaluation	microbiological culture	12 months