Use of the Amniotic Membrane in Large Wound Epithelialization

Phase 1

Completed

• Conditions: Wounds
• Interventions: Procedure: Place amniotic membrane in large wounds; Procedure: Obtaining and Cryopreservation of amniotic membrane; Drug: amniotic membrane

• Registration Number: NCT01824381
• Lead Sponsor: Red de Terapia Celular

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-04
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amniotic membrane in large wounds	Place amniotic membrane in large wounds	-
Amniotic membrane in large wounds	Obtaining and Cryopreservation of amniotic membrane	-
Amniotic membrane in large wounds	amniotic membrane	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Universitary Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain