MA/GH: Use of the Amniotic Membrane in Large Wound Epithelialization

Sponsor

Red de Terapia Celular (Industry)

Overall Status

Completed

CT.gov ID

NCT01824381

Collaborator

Public Health Service, Murcia (Other), Universidad de Murcia (Other), Hospital Universitario Virgen de la Arrixaca (Other), MurciaSalud (Other)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Wounds	Procedure: Place amniotic membrane in large wounds Procedure: Obtaining and Cryopreservation of amniotic membrane Drug: amniotic membrane	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amniotic membrane in large wounds	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 Drug: amniotic membrane

Arm

Intervention/Treatment

Experimental: Amniotic membrane in large wounds

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

Drug: amniotic membrane

Outcome Measures

Primary Outcome Measures

Safety [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 Outcome Measures

Measurement of the wound area [3 years]
To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.
Evolution of local pain measured with a visual analog scale [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.
Changes in the signaling pathways of TGFb. [1 year]
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.