NCT02350205

Brief Summary

This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
31mo left

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2015Jan 2029

First Submitted

Initial submission to the registry

January 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

12.1 years

First QC Date

January 15, 2015

Last Update Submit

July 22, 2025

Conditions

Burns

Keywords

Burn woundsBurnsSkin substitute

Outcome Measures

Primary Outcomes (3)

  • Percentage of graft take site A vs site B (Phase A 17 patients)

    Clinical assessment; Image analysis

    < 1 month

  • Percentage of graft take of all SASS (Phase A+B)

    Clinical assessment

    < 1 month

  • Percentage of graft take according to sites (Phase A+B)

    Clinical assessment

    < 1 month

Secondary Outcomes (6)

  • Scar evaluation site A vs site B (Phase A 17 patients)

    3, 6, 12, 24 and 36 months

  • Scar evaluation according to sites (Phase A+B)

    3, 6, 12, 24 and 36 months

  • Incidence of adverse events site A vs site B (Phase A 17 patients)

    24 to 36 months

  • Incidence of adverse events of all SASS (Phase A+B)

    24 to 36 months

  • Quality of life survey (Phase A+B)

    3, 6, 12, 24 and 36 months

  • +1 more secondary outcomes

Study Arms (1)

Treatment (SASS)

EXPERIMENTAL

Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Biological: Self assembled skin substitute (SASS)

Interventions

Self assembled skin substitute (SASS)BIOLOGICAL

All patients in Phase B will receive Self assembled skin substitute (SASS)

Treatment (SASS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
  • Limited availability of donor sites for autografts;
  • Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.

You may not qualify if:

  • Skin grafting needed only on the face, hands, feet, ears or genital area;
  • Connective tissue diseases;
  • Hypersensitivity to bovine proteins;
  • Coagulation disorders prior being burned;
  • Immunodeficiency prior being burned;
  • Uncontrolled diabetes prior being burned;
  • Permanent wound coverage before SASS grafts are ready;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Foothill Medcial Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Mackenzie Health Science's Centre

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

BC Children's Hospital Plastic Surgery Clinic

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Winnipeg Health Science Center

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Hospital for Sick Children (Sickkids)

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Hôpital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

CHU de Québec - Unité des grands brûlés

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Veronique J Moulin, PhD

    CHU de Quebec

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique J Moulin, PhD

CONTACT

418-525-4444veronique.moulin@fmed.ulaval.ca

Lucie Germain, PhD

CONTACT

418-525-4444lucie.germain@fmed.ulaval.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 29, 2015

Study Start

December 1, 2015

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

CA(7)