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Lack of clinical research staff
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Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrata with a split-thickness skin graft | Experimental |
| |
| Split-thickness skin graft alone | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrata | Device | Restrata is a sterile, single use device intended for use in local management of wounds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tendon Exposure | Percentage of participants with tendon exposure | 4 weeks post-operatively |
| Surface Area of Split-thickness Skin Graft Incorporation | Percentage of surface area of split-thickness skin graft incorporation | 4 weeks post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restrata With a Split-thickness Skin Graft | Restrata: Restrata is a sterile, single use device intended for use in local management of wounds |
| FG001 | Split-thickness Skin Graft Alone | Split-thickness skin graft without Restrata |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restrata With a Split-thickness Skin Graft | Restrata: Restrata is a sterile, single use device intended for use in local management of wounds |
| BG001 | Split-thickness Skin Graft Alone |
| 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 | Tendon Exposure | Percentage of participants with tendon exposure | Posted | Count of Participants | Participants | 4 weeks post-operatively |
|
|
4 weeks after skin graft harvest
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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 | Restrata With a Split-thickness Skin Graft | Restrata: Restrata is a sterile, single use device intended for use in local management of wounds |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Patient was directly admitted to the hospital due to wound-healing issues and cellulitis involving his left forearm. Treated inpatient with vancomycin and zosyn with transition to oral antibiotics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew MacEwan | Acera Surgical | 440-477-1890 | macewan@acera-surgical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2021 | Mar 27, 2023 | Prot_003.pdf |
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Split-thickness skin graft without Restrata
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | age collected | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Surface Area of Split-thickness Skin Graft Incorporation | Percentage of surface area of split-thickness skin graft incorporation | Posted | Count of Participants | Participants | 4 weeks post-operatively |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 0 |
| 3 |
| EG001 | Split-thickness Skin Graft Alone | Split thickness graft without Restrata | 0 | 2 | 0 | 2 | 0 | 2 |
|
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