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| ID | Type | Description | Link |
|---|---|---|---|
| 29478 Health Canada |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self assembled skin substitute (SASS) | Device | Wound care with self assembled skin substitute (SASS) |
| Measure | Description | Time Frame |
|---|---|---|
| wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| % of healing at 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Francois A Auger, MD | Centre hospitalier affilié universitaire de Québec | Principal Investigator |
| Lucie Germain, Ph.D. | Centre hospitalier affilié universitaire de Québec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier affilie universitaire de Quebec | Québec | Quebec | G1J 1Z4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12084997 | Background | Pouliot R, Larouche D, Auger FA, Juhasz J, Xu W, Li H, Germain L. Reconstructed human skin produced in vitro and grafted on athymic mice. Transplantation. 2002 Jun 15;73(11):1751-7. doi: 10.1097/00007890-200206150-00010. | |
| 10476918 | Background | Michel M, L'Heureux N, Pouliot R, Xu W, Auger FA, Germain L. Characterization of a new tissue-engineered human skin equivalent with hair. In Vitro Cell Dev Biol Anim. 1999 Jun;35(6):318-26. doi: 10.1007/s11626-999-0081-x. |
| Label | URL |
|---|---|
| LOEX research laboratory website | View source |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |