Status:
COMPLETED
Use of the Amniotic Membrane in Large Wound Epithelialization
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Public Health Service, Murcia
Universidad de Murcia
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01824381
Start Date
July 1 2012
End Date
March 1 2017
Last Update
March 30 2017
Active Locations (1)
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1
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120