Trial | NCT01824381  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amniotic membrane ...

  • Study Participants

    6
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
Study Started
Jul 31
2012
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Mar 30
2017

Procedure Place amniotic membrane in large wounds

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.

Procedure Obtaining and Cryopreservation of amniotic membrane

Amniotic membrane in large wounds Experimental

Criteria 

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.
No Results Posted