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Active, Not Recruiting

NCT Number: NCT04171661

Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epidermolysis Bullosa Dystrophica Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Epidermolysis Bullosa Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

This clinical trial was custom designed for one patient

Treatment and study plan

SASS

Biological

SASS applied on chronic skin wounds as skin graft

Primary outcomes

  1. Percent reduction in wound surface area

    Time frame: 2 weeks

    Clinical assessment

Secondary outcomes

  1. Graft failure

    Time frame: 2 weeks

    Clinical assessment

  2. Number of subsequent re-transplantation

    Time frame: 3 years

    Number

  3. Time (in weeks) to 50% reduction in the surface area of the wounds;

    Time frame: 3 years

    Clinical assessment

  4. Time (in weeks) to complete healing

    Time frame: 3 years

    Clinical assessment

  5. Changes in pain scores

    Time frame: 3 years

    10 point visual analog scale where 0 is none and 10 the worst pain

  6. Changes in itch scores where 0 is none and 10 the worst itch

    Time frame: 3 years

    10 point scale

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

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

Acronym: SASS

Important dates

Study start
2019
Primary completion
2019
Study completion
2026
First posted
Nov 21, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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