Clinical trial NCT02350205: SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
Official title: SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Burns
Keywords: Burn wounds
Burns
Skin substitute
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Percentage of graft take site A vs site B (Phase A 17 patients)
timeFrame: < 1 month
measure: Percentage of graft take of all SASS (Phase A+B)
timeFrame: < 1 month
measure: Percentage of graft take according to sites (Phase A+B)
timeFrame: < 1 month
Secondary outcomes:
measure: Scar evaluation site A vs site B (Phase A 17 patients)
timeFrame: 3, 6, 12, 24 and 36 months
measure: Scar evaluation according to sites (Phase A+B)
timeFrame: 3, 6, 12, 24 and 36 months
measure: Incidence of adverse events site A vs site B (Phase A 17 patients)
timeFrame: 24 to 36 months
measure: Incidence of adverse events of all SASS (Phase A+B)
timeFrame: 24 to 36 months
measure: Quality of life survey (Phase A+B)
timeFrame: 3, 6, 12, 24 and 36 months
measure: Ratio harvested surface vs covered surface (Phase A+B)
timeFrame: 1 month
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothill Medcial Centre
state: Alberta
city: Edmonton
country: Canada
facility: Mackenzie Health Science's Centre
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital Plastic Surgery Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Science Center
state: Manitoba
city: Toronto
country: Canada
facility: Hospital for Sick Children (Sickkids)
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Sainte Justine
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Unité des grands brûlés
Study officials:
affiliation: CHU de Quebec
name: Veronique J Moulin, PhD
role: PRINCIPAL_INVESTIGATOR
References: