Menu
Recruiting NCT02350205

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

Phase I / Phase II Interventional Burns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self assembled skin substitute (SASS).
Who it may be relevant to
Registry conditions: Burns. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.

Overview

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.

Interventions

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

Primary outcome measures

  • Percentage of graft take site A vs site B (Phase A 17 patients) [Time frame: < 1 month]
  • Percentage of graft take of all SASS (Phase A+B) [Time frame: < 1 month]
  • Percentage of graft take according to sites (Phase A+B) [Time frame: < 1 month]
Secondary outcome measures (6)
  • Scar evaluation site A vs site B (Phase A 17 patients) [Time frame: 3, 6, 12, 24 and 36 months]
  • Scar evaluation according to sites (Phase A+B) [Time frame: 3, 6, 12, 24 and 36 months]
  • Incidence of adverse events site A vs site B (Phase A 17 patients) [Time frame: 24 to 36 months]
  • Incidence of adverse events of all SASS (Phase A+B) [Time frame: 24 to 36 months]
  • Quality of life survey (Phase A+B) [Time frame: 3, 6, 12, 24 and 36 months]
  • Ratio harvested surface vs covered surface (Phase A+B) [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 8 centers
  • Foothill Medcial Centre — Calgary
  • Mackenzie Health Science's Centre — Edmonton
  • Vancouver General Hospital — Vancouver
  • BC Children's Hospital Plastic Surgery Clinic — Vancouver
  • Winnipeg Health Science Center — Winnipeg
  • Hospital for Sick Children (Sickkids) — Toronto
  • Hôpital Sainte Justine — Montreal
  • CHU de Québec - Unité des grands brûlés — Québec

Identifiers

NCT: NCT02350205 · LOEX 014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗