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| Name | Class |
|---|---|
| MedDRA Assistance Inc | UNKNOWN |
| Advanced Clinical Research Services, LLC | OTHER |
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This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants (within patient control) | Experimental | All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCell Treatment | Device |
| ||
| Skin Graft |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas. | Prior to or at 8 weeks |
| Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas. | Prior to or at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). | At 24 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James H Holmes, IV, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center at Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| MedStar Washington Hospital Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: All Participants (Within Patient Control) | Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before thee areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: All Participants (Within Patient Control) | All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated). |
| 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 Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) | Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas. | Per Protocol Population | Posted | Count of Participants | Participants | Prior to or at 8 weeks |
|
52 Weeks
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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 | Experimental: All Participants (Within Patient Control) | All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Research | AVITA Medical | 661-367-9170 | clinicaltrial@avitamedical.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D016038 | Skin Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
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| Procedure |
|
| Patient's Satisfaction/Treatment Preference | At 24 Week |
| Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T | Week 24 |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| North Carolina Jaycee Burn Center | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103-3409 | United States |
| USAISR - US Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
Wound received an autograft consistent with the investigator's pre-identified graft plan (Control). |
|
|
| Primary | Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas. | Intent-to-Treat Population (primary analysis) | Posted | Geometric Mean | Standard Deviation | cm2 | Prior to or at 8 weeks |
|
|
|
|
| Secondary | Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). | Per-Protocol Population | Posted | Mean | Standard Deviation | units on a scale | At 24 Week |
|
|
|
| Secondary | Patient's Satisfaction/Treatment Preference | Per-Protocol Population | Posted | Count of Participants | Participants | At 24 Week |
|
|
|
| Secondary | Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T | Per-Protocol Population | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| 1 |
| 30 |
| 12 |
| 30 |
| 26 |
| 30 |
|
| Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Re-grafting Due to Graft Failure | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| Surgery for Failed Skin Graft | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| Graft Loss to Left Lower Extremity (LLE) | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| Re-Grafting Due to Graft Failure | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Severe Contracture left hand, left wrist, left fingers and left lower eyelid | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Open Wound Left Elbow | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Increased Elbow Pain, Right | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Inability to Move Right Elbow | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Intractable Pain Right Arm | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Cellulitis Left Index Finger | Infections and infestations | Systematic Assessment | NON-STUDY AREA |
|
| Cellulitis to Non-Study Donor Site | Infections and infestations | Systematic Assessment | NON-STUDY AREA |
|
| Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Graft Shearing/Loss to Left Calf | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Patient Concern for Infection | General disorders | Systematic Assessment | NON-STUDY AREA |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | Systematic Assessment |
|
| Acute respiratory distress syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right Frontotemporal Subarachnoid Hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Pain/Soreness Under Right Arm | Musculoskeletal and connective tissue disorders | Systematic Assessment | RECELL |
|
| Chronic Pain | General disorders | Systematic Assessment | RECELL |
|
| Scar Revision | Surgical and medical procedures | Systematic Assessment | RECELL |
|
| Neuropathic Pain | Nervous system disorders | Systematic Assessment | RECELL |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL |
|
| Burning | Nervous system disorders | Systematic Assessment | RECELL |
|
| Shearing of Graft on Site A 0.9x1 cm | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Delayed Healing | General disorders | Systematic Assessment | RECELL |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL |
|
| Increased Pain | General disorders | Systematic Assessment | RECELL |
|
| Abrasion | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Scratch on Back | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Small area of graft loss on anterior right lower extremity | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Chronic non-healing wounds to RLE secondary to DM type 1 | Skin and subcutaneous tissue disorders | Systematic Assessment | RECELL |
|
| Graft Loss Posterior Back | Injury, poisoning and procedural complications | Systematic Assessment | RECELL |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | CONTROL |
|
| Mildly Infected | Infections and infestations | Systematic Assessment | CONTROL |
|
| Chronic Pain | General disorders | Systematic Assessment | CONTROL |
|
| Scar Revision | Surgical and medical procedures | Systematic Assessment | CONTROL |
|
| Neuropathic Pain | Nervous system disorders | Systematic Assessment | CONTROL |
|
| Graft Loss | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| Delayed Healing | General disorders | Systematic Assessment | CONTROL |
|
| Ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | CONTROL |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | CONTROL |
|
| Burning | Nervous system disorders | Systematic Assessment | CONTROL |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment | CONTROL |
|
| Abrasion to shin | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| White creamy exudates left lower leg | General disorders | Systematic Assessment | CONTROL |
|
| Infection of the L Lower Leg | Infections and infestations | Systematic Assessment | CONTROL |
|
| Chronic non-healing wounds to LLE secondary to DM type 1 | Skin and subcutaneous tissue disorders | Systematic Assessment | CONTROL |
|
| Graft loss posterior back | Injury, poisoning and procedural complications | Systematic Assessment | CONTROL |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | DONOR SITE |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | DONOR SITE |
|
| Blisters | Skin and subcutaneous tissue disorders | Systematic Assessment | DONOR SITE |
|
| Left thigh donor site with purulent drainage and open areas | Infections and infestations | Systematic Assessment | DONOR SITE |
|
| Pain right hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Chronic pain | General disorders | Systematic Assessment | NON-STUDY AREA |
|
| Scar revision | Surgical and medical procedures | Systematic Assessment | NON-STUDY AREA |
|
| Neuropathic pain | Nervous system disorders | Systematic Assessment | NON-STUDY AREA |
|
| Heterotrophic ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Burning | Nervous system disorders | Systematic Assessment | NON-STUDY AREA |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Contracture, right hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Blisters to left thigh non-study donor | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Blisters to right thigh non-study graft | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Non-healing wound to posterior left upper arm | General disorders | Systematic Assessment | NON-STUDY AREA |
|
| Abrasion to knee | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Scratch at the back | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Contact dermatitis at neck and upper back | Skin and subcutaneous tissue disorders | Systematic Assessment | NON-STUDY AREA |
|
| Graft loss l breast | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Medial left upper arm graft loss | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Arm burn cellulitis | Infections and infestations | Systematic Assessment | NON-STUDY AREA |
|
| Graft loss chest wall at inner axilla | Injury, poisoning and procedural complications | Systematic Assessment | NON-STUDY AREA |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Klebsiella Pneumonia | Infections and infestations | Systematic Assessment |
|
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| D062109 |
| Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |