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Tissue Engineering
Skin Substitute for Epidermolysis Bullosa (SASS Trial)
Phase < 1
Waitlist Available
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new type of skin substitute on a patient with a chronic skin condition. The hope is that this new skin will help the patient's wounds heal.
Who is the study for?
This trial is specifically designed for a single patient with dystrophic epidermolysis bullosa, who has chronic open wounds not healing with dressings or medications. There are no general eligibility criteria as it's tailored to this one individual.
What is being tested?
The trial is testing Self-Assembled Skin Substitutes (SASS) on a patient with severe skin condition, aiming to cover and potentially heal chronic open wounds that haven't responded to other treatments.
What are the potential side effects?
Since the study is custom-designed for one person, side effects will be monitored closely but may include typical reactions related to skin grafting such as infection, rejection of the substitute, or inflammation at the wound site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent reduction in wound surface area
Secondary study objectives
Changes in itch scores where 0 is none and 10 the worst itch
Changes in pain scores
Graft failure
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SASSExperimental Treatment1 Intervention
SASS applied on chronic skin wounds as skin graft
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
172 Previous Clinical Trials
109,674 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
711 Previous Clinical Trials
6,958,279 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
11 Patients Enrolled for Epidermolysis Bullosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This trial is designed for one specific patient, so there are no general requirements for participation.
Research Study Groups:
This trial has the following groups:- Group 1: SASS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.