NCT01948934
Completed
Phase 1
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 site in 1 country6 target enrollmentJune 2012
ConditionsWound
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Wound
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- serious adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds
Detailed Description
Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute wounds in granulation phase with a minimum surface of 100cm2
- •≥ 18 years
- •signing informed consent form
- •guarantee adherence to protocol
Exclusion Criteria
- •chronic arterial insufficiency
- •pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
- •involved in other assay
- •previous disease; kidney, heart, hepatic, systemic or immune
- •inability to understand informed consent form
Outcomes
Primary Outcomes
serious adverse events
Time Frame: 12 months
inflammatory changes
Time Frame: 12 months
Secondary Outcomes
- wound evaluation(12 months)
- immunological evaluation(12 months)
- histological evaluation(12 months)
- microbiological evaluation(12 months)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly PopulationVenous Leg UlcerNCT06544564BioLab Holdings150
Completed
Not Applicable
The effect of amniotic membrane on post cesarean paicaesarean section.Single delivery by caesarean sectionIRCT2016040516110N3Vice Chancellor for research of Gerash University of Medical Sciences90
Terminated
Phase 2
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant KeratitisKeratitisNCT05250583TBF Genie Tissulaire5
Completed
Not Applicable
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg UlcersVenous Leg UlcerNCT01552447MiMedx Group, Inc.98
Active, not recruiting
Not Applicable
The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective StudyMacular HolesNCT04904679Hospital Oftalmologico de Sorocaba23