extensive wounds MedDRA version: 14.1 Level: PT Classification code 10062932 Term: Wound treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: AM placed over an impregnated dressing of Tulgrasum. Membrana amniótic sobre un apósito de Tulgrasum
Pharmaceutical Form: Impregnated dressing
INN or Proposed INN: amniotic membrane
Curr
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute wounds in the granulation phase with a minimum surface of 100 cm2. Patients who are 18 or older. Patients who offer enough guarantees of adhesion to the protocol. Patients who have signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Patients who have symptomatic chronic artery failure. Patients with severe systematic diseases. Diabetic patients. Inclusion in other clinical trials. Inability to understand informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the safety of the application of the AM in extensive wounds in the granulation phase.;Primary end point(s): Absence of severe adverse events related in any possible, probable or certain way with the procedure. Absence of clinical inflamatoy changes;Timepoint(s) of evaluation of this end point: After positioning each AM, the wound will be controlled at day four. After positioning the final AM a control visit will be carried out every 7 days for 3 months and afterwards every 3 months until 1 year of evolution time has passed;Secondary Objective: To assess the effects of the application of the AM on the reepithelization of wounds through the reduction over time of the area unit of the wound To assess the effects of AM application for treating patient symptomatology through the evolution of local pain through a visual analogue scale To study changes in the signally pathways of TGF? in the epithelium of patients included for AM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Wound Assessment: Clinical assessment carried out by the specialist in Surgery: ? Inflammatory state of the wound. ? Redness (yes/no). ? Flushing (yes/no). ? Inflammatory tumor (yes/no). ? State of perilesional skin (normal/abnormal). ? Appearance of local neoplasias (yes/no). ? Assessment of symptoms related with the wound ? Local pain assessed using the visual analogue scale between 0 and 10, 0 being no pain and 10 the worst pain possible. ? Analgesic required classified into 3 stratum, according to the analgesic scale of the WHO. ? Immunological Assessment ? Detection of class I HLA anti-bodies (present/absent) ? Chimerism of the wound through detection of STRs (% donor/% recipient) ? Histological Assessment ? Anatomopathological Assessment of seried biopsies of the wound and the re-epithelization border. ? Analysis of the TGF? signalling pathway in the same biopsies. ? Microbiological Assessment ? Microbiological cultivation on the wound surface (positive/negative).;Timepoint(s) of evaluation of this end point: After positioning the final AM a control visit will be carried out every 7 days for 3 months and afterwards every 3 months until 1 year of evolution time has passed. All secondary endpoints will be controlled. | — |
Countries
Spain
Contacts
Public ContactClinical Trial Information
Hospital Universitario Virgen de la Arrixaca
Outcome results
None listed