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New treatment option for Burns
Official title SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
ClinicalTrials.gov ID: NCT02350205
What this study is testing
What is Self assembled skin substitute (SASS)?
Self assembled skin substitute (SASS) is an investigational medicine, being studied as a potential treatment for burns.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
- Limited availability of donor sites for autografts;
- Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.
You likely can't join if
- Skin grafting needed only on the face, hands, feet, ears or genital area;
- Connective tissue diseases;
- Hypersensitivity to bovine proteins;
- Coagulation disorders prior being burned;
- Immunodeficiency prior being burned;
- Uncontrolled diabetes prior being burned;
See the full eligibility criteria
- Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
- Limited availability of donor sites for autografts;
- Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.
- Skin grafting needed only on the face, hands, feet, ears or genital area;
- Connective tissue diseases;
- Hypersensitivity to bovine proteins;
- Coagulation disorders prior being burned;
- Immunodeficiency prior being burned;
- Uncontrolled diabetes prior being burned;
- Permanent wound coverage before SASS grafts are ready;
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.