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| ID | Type | Description | Link |
|---|---|---|---|
| WFUHS 40269 | Other Grant/Funding Number | AFIRM |
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The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StrataGraft skin tissue | Experimental | All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrataGraft Skin Tissue | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Closure of the Treatment Sites at Three Months | Determination of complete wound closure of both treatment sites was evaluated at 3 months. | 3 months |
| Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 | The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Integrated Health Systems, Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| University of Colorado Hospital Burn Center |
All subjects were treated with both StrataGraft skin tissue and autograft as part of the intrapatient comparator design. Two comparable excised areas of deep partial-thickness burn per subject were randomized to receive a single application of autograft or StrataGraft skin tissue.
The study evaluated the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns. Subjects had surgical excision and placement of StrataGraft skin tissue and autograft. The trial was conducted at six clinical sites throughout the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | StrataGraft Skin Tissue : Autograft | Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | StrataGraft Skin Tissue : Autograft | Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Wound Closure of the Treatment Sites at Three Months | Determination of complete wound closure of both treatment sites was evaluated at 3 months. | Intent-to-Treat (ITT) Population consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status. Participants with available data were analyzed. | Posted | Count of Participants | Participants | 3 months |
|
Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
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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 : Autograft | Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Lokuta | Stratatech Corporation, a Mallinckrodt Company | 608-441-8358 | mlokuta@stratatechcorp.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| UT-Southwestern Medical Center | Dallas | Texas | 75390-9158 | United States |
| U.S. Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234-6315 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Autograft | The current standard of care for the management of severe burns and other skin trauma is excision of the necrotic tissue followed by autografting. |
|
|
| Primary | Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 | The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined. | ITT Population - consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status. | Posted | Median | Full Range | Percentage of area | 28 days |
|
|
|
| 0 |
| 30 |
| 6 |
| 30 |
| 27 |
| 30 |
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| Impaired healing | General disorders | MedDRA | Systematic Assessment | AE considered possibly related to the StrataGraft skin tissue treatment due to inappropriate selection of full-thickness wound that did not meet study inclusion. |
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| Pain | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Thermal burn | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Transplant failure | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Abscess, limb | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Adverse events (AE) were judged to be possibly related to treatment with StrataGraft skin tissue. |
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| Cardiac failure, congestive | Cardiac disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Cephalohematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Chest pain | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Chills | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Corneal neovascularization | Eye disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Debridement | Surgical and medical procedures | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Eyelid oedema | Eye disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Gout | Immune system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Graft infection | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hyperaesthesia | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypermetabolism | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Impaired healing | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Intestinal functional disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Keratitis, fungal | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Muscule contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pain | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Peroneal nerve palsy | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Prostate infection | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Three subjects adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. Two subjects AE were judged to be possibly related to treatment with StrataGraft skin tissue. |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Oedema | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Adverse events (AE) were judged to be probably related to treatment with StrataGraft skin tissue. |
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| Red man syndrome | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Renal failure, acute | Renal and urinary disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Sarcoidosis | Immune system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Sensory disturbance | Nervous system disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Sepsis | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Wisdom teeth removal | Surgical and medical procedures | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Wound drainage | Surgical and medical procedures | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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| Wound infection, Staphylococcal | Infections and infestations | MedDRA | Systematic Assessment | All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. |
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