Integra®: A commercially available dermal bovine matrix that is widely used for wound and burn care, Integra® Dermal Regeneration Template licensed device (Medical Device Active License Listing No. 229).
Integra®-SC: A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.
Study summary
Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Aged ≥ 18 years.
* Total body surface area (TBSA) ≥ 5%.
* Full-thickness burn requiring operative procedures.
* Admitted ≤ 120 hours following burn.
* Injury location includes a contralateral area.
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
* Patients who are moribund.
* Known infection with any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Human T-lymphotropic Virus (HTLV), Syphilis, or West Nile Virus.
* Injury location limited to face and/or hands.
* Pregnancy.
* Active cancer and currently undergoing treatment.
Primary outcome measure(s)
Safety - Number of participants with surgical site infections — Acute hospitalization (1-4 months post admission depending on severity of injury) The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, surgical site infections that require an additional (unplanned) operation will be recorded as an in-hospital complication.
Safety - Number of participants with non-healing wounds — Acute hospitalization (1-4 months post admission depending on severity of injury) The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, non-healing wounds that require an additional (unplanned) operation will be recorded as an in-hospital complication.
Safety - Number of patients with poor scarring requiring additional (unplanned) operation — Discharge to to 1 year post-discharge The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, poor scarring requiring an additional (unplanned) operation will be recorded as a late-onset complication.
Trial sites (1)
Facility
City
Region
Status
Hamilton General Hospital
Hamilton
Ontario
More Hamilton Health Sciences Corporation trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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