A Phase 1 interventional study of Integra® and Integra®-SC in Burns, sponsored by Hamilton Health Sciences Corporation. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Hamilton Health Sciences Corporation · Phase 1, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's planned enrollment of 29 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface.
Device: Integra®
After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied.
Device: Integra®-SC
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).
A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.
Safety - Number of participants with surgical site infections
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.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Safety - Number of participants with non-healing wounds
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.
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
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.
Time frame: Discharge to to 1 year post-discharge
Time of wound healing
Time from wound excision to 95% healing of the burned area will be recorded. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Arterial bleeding from the wound site
Arterial bleeding from the wound site will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Signs of wound infection
Classic signs of wound infection will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Detachment of Integra®-SC
The detachment of the entire Integra®-SC from the wound site will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Abnormal scar formation
The formation of hypertrophic scars or keloids will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Scar Formation - Vascularity of the healed area
Vascularity of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Vascularity is scored from 0 to 3, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.
Time frame: Discharge to 1 year post-discharge
Scar formation - Pigmentation of the healed area
Pigmentation of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Pigmentation is scored from 0 to 2, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.
Time frame: Discharge to 1 year post-discharge
Scar formation - Pliability of the healed area
Pliability of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Pliability is scored from 0 to 5, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.
Time frame: Discharge to 1 year post-discharge
Scar formation - Height of the healed area
The height of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Height is scored from 0 to 3, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.
Time frame: Discharge to 1 year post-discharge
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation