Venous Ulcers
Conditions
Keywords
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care
Brief summary
The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.
Detailed description
The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.
Interventions
Wound care with self assembled skin substitute (SASS)
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women from 18 to 85 years old 2. Have a venous ulcer or a mixed ulcer
Exclusion criteria
Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound closure | — |
Secondary
| Measure | Time frame |
|---|---|
| % of healing at 6 months of treatment | — |
Countries
Canada
Outcome results
None listed