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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-16-C-0202 | Other Grant/Funding Number | DoD |
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Protracted enrollment and limited wound closure in the first three subjects
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About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StrataGraft skin tissue | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrataGraft Skin Tissue | Biological | StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined. | 3 months |
| Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months | Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months | within 3 months | |
| Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months | within 3, 6 and 12 months |
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Inclusion Criteria:
Men and women aged 18-65 years, inclusive
Written informed consent
Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
Full-thickness complex skin defects requiring excision and autografting
Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
For thermal burns only, first excision and grafting of treatment sites
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| Wake Forest University Baptist Medical Center |
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005054) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
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| ID | Title | Description |
|---|---|---|
| FG000 | StrataGraft Skin Tissue | StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants
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| ID | Title | Description |
|---|---|---|
| BG000 | StrataGraft Skin Tissue | StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months | The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined. | All participants | Posted | Number | percentage of treatment site | 3 months |
|
3 months
Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | StrataGraft Skin Tissue | StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft complication | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment | Unrelated to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft complication | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
Due to protracted enrollment and limited wound closure in the first three subjects, the Sponsor decided to end further enrollment and the study was terminated with only 3 subjects enrolled into Cohort 1. No participants were enrolled into Cohort 2. Therefore, posted results include primary outcome measures for the 3 subjects enrolled, but no data for the secondary outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-844-2830 | 5 | clinicaltrials@mnk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2017 | Nov 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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See detailed description
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| Autograft | Procedure | The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound. |
|
| Percent Wound Closure at 3, 6, and 12 Months | within 3, 6, and 12 Months |
| Cosmesis of Treatment Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | within 3, 6, and 12 Months |
| Cosmesis of Donor Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | within 3, 6, and 12 Months |
| Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 | at days 3, 7, 14, 21, and 28 |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| U.S. Army Institute of Surgical Research Adult Burn Center | Fort Sam Houston | Texas | 78234-6315 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months | Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage | All participants | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months | Data were not collected | Posted | within 3 months |
|
|
| Secondary | Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months | Data were not collected | Posted | within 3, 6 and 12 months |
|
|
| Secondary | Percent Wound Closure at 3, 6, and 12 Months | Data were not collected | Posted | within 3, 6, and 12 Months |
|
|
| Secondary | Cosmesis of Treatment Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | Data were not collected | Posted | within 3, 6, and 12 Months |
|
|
| Secondary | Cosmesis of Donor Sites at 3, 6, and 12 Months | Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance | Data were not collected | Posted | within 3, 6, and 12 Months |
|
|
| Secondary | Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 | Data were not collected | Posted | at days 3, 7, 14, 21, and 28 |
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
|
| Fungal skin infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hyperglycaemia | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
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