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Clinical Trials/NCT04171661
NCT04171661Active, not recruitingEarly Phase 1

SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa

CHU de Quebec-Universite Laval1 site in 1 country1 target enrollmentStarted: December 10, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
1
Locations
1
Primary Endpoint
Percent reduction in wound surface area
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •This clinical trial was custom designed for one patient

Exclusion Criteria

  • Not provided

Arms & Interventions

SASS

Experimental

SASS applied on chronic skin wounds as skin graft

Intervention: SASS (Biological)

Outcomes

Primary Outcomes

Percent reduction in wound surface area

Time Frame: 2 weeks

Clinical assessment

Secondary Outcomes

  • Changes in pain scores(3 years)
  • Graft failure(2 weeks)
  • Time (in weeks) to 50% reduction in the surface area of the wounds;(3 years)
  • Number of subsequent re-transplantation(3 years)
  • Time (in weeks) to complete healing(3 years)
  • Changes in itch scores where 0 is none and 10 the worst itch(3 years)

Investigators

Sponsor
CHU de Quebec-Universite Laval
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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