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Completed

NCT Number: NCT01948934

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

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

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Key information

Conditions

Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gregorio Castellanos Escrig MD

Murcia, El Palmar, 30120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic membrane in big wounds

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

Primary outcomes

  1. serious adverse events

    Time frame: 12 months

  2. inflammatory changes

    Time frame: 12 months

Secondary outcomes

  1. wound evaluation

    Time frame: 12 months

    inflammatory condition of the wound,surface,

  2. immunological evaluation

    Time frame: 12 months

    anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection

  3. histological evaluation

    Time frame: 12 months

    Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy

  4. microbiological evaluation

    Time frame: 12 months

    microbiological culture

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2013
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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