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Not yet recruiting NCT05344521

A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells

Phase I 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: Integra®, Integra®-SC.
Who it may be relevant to
Registry conditions: Burns. Basic parameters: from 18 years · 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 →

Overview

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.

Interventions

  • Device 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).
  • Device Integra®-SC
    A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.

Primary outcome measures

  • Safety - Number of participants with surgical site infections [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Safety - Number of participants with non-healing wounds [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Safety - Number of patients with poor scarring requiring additional (unplanned) operation [Time frame: Discharge to to 1 year post-discharge]
Secondary outcome measures (9)
  • Time of wound healing [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Quality of skin regeneration - Arterial bleeding from the wound site [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Quality of skin regeneration - Signs of wound infection [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Quality of skin regeneration - Detachment of Integra®-SC [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Quality of skin regeneration - Abnormal scar formation [Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)]
  • Scar Formation - Vascularity of the healed area [Time frame: Discharge to 1 year post-discharge]
  • Scar formation - Pigmentation of the healed area [Time frame: Discharge to 1 year post-discharge]
  • Scar formation - Pliability of the healed area [Time frame: Discharge to 1 year post-discharge]
  • Scar formation - Height of the healed area [Time frame: Discharge to 1 year post-discharge]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Hamilton General Hospital — Hamilton

Identifiers

NCT: NCT05344521 · 15229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗