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This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SASS) | Experimental | Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self assembled skin substitute (SASS) | Biological | All patients in Phase B will receive Self assembled skin substitute (SASS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of graft take site A vs site B (Phase A 17 patients) | Clinical assessment; Image analysis | < 1 month |
| Percentage of graft take of all SASS (Phase A+B) | Clinical assessment | < 1 month |
| Percentage of graft take according to sites (Phase A+B) | Clinical assessment | < 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Scar evaluation site A vs site B (Phase A 17 patients) | Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images; | 3, 6, 12, 24 and 36 months |
| Scar evaluation according to sites (Phase A+B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronique J Moulin, PhD | Contact | 418-525-4444 | 61715 | veronique.moulin@fmed.ulaval.ca |
| Lucie Germain, PhD | Contact | 418-525-4444 | 61696 | lucie.germain@fmed.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Veronique J Moulin, PhD | CHU de Quebec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothill Medcial Centre | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
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Cutometer; Mexameter; Dermascan; Images;
| 3, 6, 12, 24 and 36 months |
| Incidence of adverse events site A vs site B (Phase A 17 patients) | Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other | 24 to 36 months |
| Incidence of adverse events of all SASS (Phase A+B) | Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other | 24 to 36 months |
| Quality of life survey (Phase A+B) | Survey BSHS-B ( brief version of the Burn Specific Health Scale) | 3, 6, 12, 24 and 36 months |
| Ratio harvested surface vs covered surface (Phase A+B) | Planimetric analysis; Clinical assessment; Images; Image analysis; | 1 month |
| Mackenzie Health Science's Centre | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| BC Children's Hospital Plastic Surgery Clinic | Recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
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| Winnipeg Health Science Center | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
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| Hospital for Sick Children (Sickkids) | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Hôpital Sainte Justine | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| CHU de Québec - Unité des grands brûlés | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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