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

February 16, 2023 updated by: CHU de Quebec-Universite Laval

SASS 3: Self-Assembled Skin Substitute (SASS) 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

This clinical trial was custom designed for one patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SASS
SASS applied on chronic skin wounds as skin graft
Biological: SASS
SASS applied on chronic skin wounds as skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent reduction in wound surface area
Time Frame: 2 weeks
Clinical assessment
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft failure
Time Frame: 2 weeks
Clinical assessment
2 weeks
Number of subsequent re-transplantation
Time Frame: 3 years
Number
3 years
Time (in weeks) to 50% reduction in the surface area of the wounds;
Time Frame: 3 years
Clinical assessment
3 years
Time (in weeks) to complete healing
Time Frame: 3 years
Clinical assessment
3 years
Changes in pain scores
Time Frame: 3 years
10 point visual analog scale where 0 is none and 10 the worst pain
3 years
Changes in itch scores where 0 is none and 10 the worst itch
Time Frame: 3 years
10 point scale
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

December 24, 2019

Study Completion (Anticipated)

December 10, 2024

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOEX 019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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