Wounds
Conditions
Keywords
extensive wounds, amniotic membrane, healing, patients, phase granulation
Brief summary
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
Interventions
PROCEDUREPlace amniotic membrane in large wounds
After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed. The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue. We will place a new membrane weekly to a maximum of 6 times.
PROCEDUREObtaining and Cryopreservation of amniotic membrane
Sponsors
Public Health Service, Murcia
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
MurciaSalud
Red de Terapia Celular
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed