Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

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Dystrophic epidermolysis bullosa
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Brief Title

Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

Official Title

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

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 Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Percent reduction in wound surface area

Secondary Outcome

 Graft failure

Condition

Epidermolysis Bullosa Dystrophica

Intervention

SASS

Study Arms / Comparison Groups

 SASS
Description:  SASS applied on chronic skin wounds as skin graft

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

1

Start Date

December 10, 2019

Completion Date

December 10, 2024

Primary Completion Date

December 24, 2019

Eligibility Criteria

        This clinical trial was custom designed for one patient

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT04171661

Organization ID

LOEX 019

Responsible Party

Sponsor

Study Sponsor

CHU de Quebec-Universite Laval

Collaborators

 The Hospital for Sick Children

Study Sponsor

, ,

Verification Date

January 2021