Wound
Conditions
Keywords
Skin, Injury, Membrane amniotic, Wound
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.
Interventions
PROCEDUREAmniotic membrane in big wounds
The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serious adverse events | 12 months |
| inflammatory changes | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed