Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Phase 1
Completed
- Conditions
- Wound
- Registration Number
- NCT01948934
- Lead Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method serious adverse events 12 months inflammatory changes 12 months
- Secondary Outcome Measures
Name Time Method wound evaluation 12 months inflammatory condition of the wound,surface,
immunological evaluation 12 months anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection
histological evaluation 12 months Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy
microbiological evaluation 12 months microbiological culture
Trial Locations
- Locations (1)
Gregorio Castellanos Escrig MD
🇪🇸Murcia, El Palmar, Spain
Gregorio Castellanos Escrig MD🇪🇸Murcia, El Palmar, Spain