Skip to main content
OpenTrials
Completed

NCT Number: NCT01824381

Use of the Amniotic Membrane in Large Wound Epithelialization

The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Universitary Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

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 area of 100 cm2.
  • Patients 18 or more years.
  • Patients offering sufficient guarantees of adherence to protocol.
  • Sign the written informed consent.
  • Meet all inclusion criteria.

Exclusion criteria

  • Patients with symptomatic chronic arterial insufficiency.
  • Patients who are pregnant
  • Patients in active lactation
  • Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
  • Complete abstinence from sexual intercourse
  • Surgical sterilization (tubal ligation)
  • Surgical sterilization of the partner (vasectomy)
  • Implanted or injectable hormonal contraceptives, oral *
  • Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control.

These reliable contraception must be maintained during their participation in the study.

  • Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test.
  • Participation in other clinical trials.
  • Inability to understand informed consent.

Treatment and study plan

Place amniotic membrane in large wounds

Procedure

After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed.

The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue.

We will place a new membrane weekly to a maximum of 6 times.

Obtaining and Cryopreservation of amniotic membrane

Procedure

amniotic membrane

Drug

Primary outcomes

  1. Safety

    Time frame: Last revision at 3 years after surgery.

    No serious adverse events possibly, probably or definitely related with the procedure.

    No appearance of clinical inflammatory changes.

Secondary outcomes

  1. Measurement of the wound area

    Time frame: 3 years

    To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.

  2. Evolution of local pain measured with a visual analog scale

    Time frame: 1 year

    To assess the effects of the application of amniotic membrane in the symptomatology of patients through the development of local pain measured with a visual analog scale.

  3. Changes in the signaling pathways of TGFb.

    Time frame: 1 year

    To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • Hospital Universitario Virgen de la Arrixaca
  • MurciaSalud
  • Public Health Service, Murcia
  • Universidad de Murcia

Registry information

Official study title

Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.

Acronym: MA/GH

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2013
Registry last updated
Mar 30, 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.

Published trials that share one or more normalized conditions with this study.