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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 99915A | Other Identifier | Wake Forest University Health Sciences |
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The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.
The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . While the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is typically covered with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these complications, several groups have described a technique of placing Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide a thicker support and decrease overall morbidity associated with the defect. These studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. However, the largest study to date has included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic STSG to show effectiveness of this technique when compared to a classic repair. Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and those repaired with one step Integra and STSG applied at the same time. These subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Experimental | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. |
|
| Split Thickness Skin Graft (STSG) | Active Comparator | reconstruction as dictated by the protocol. They will either receive 1) a 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integra plus STSG | Device | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Skin Graft Necrosis. | Number of participants with skin graft necrosis. | 1 year |
| Vancouver Scar Scale | The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome. | 1 Year |
| Vancouver Scar Scale - Pigmentation | Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome. | 1 year |
| Vancouver Scar Scale - Vascularity | Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | 1 year |
| Vancouver Scar Scale - Pliability | Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome. | 1 year |
| Vancouver Scar Scale - Height | Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | 1 year |
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. | 3 month |
| Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Molnar, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Integra and a Split Thickness Skin Graft (STSG) | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG |
| FG001 | Split Thickness Skin Graft (STSG) | reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Integra and a Split Thickness Skin Graft (STSG) | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG |
| 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 Skin Graft Necrosis. | Number of participants with skin graft necrosis. | Posted | Number | participants | 1 year |
|
Data was collected during the 1 year of study activities.
Definitions do not differ.
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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 | Integra and a Split Thickness Skin Graft (STSG) | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject deceased | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Molnar | Wake Forest Baptist Health | 336-716-4171 | jmolnar@wakehealth.edu |
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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 | Nov 10, 2017 | May 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| STSG | Procedure | 0.012mm STSG |
|
| Pre-op |
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 3 month |
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 6 months |
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 1 year |
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | pre-op |
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 3 month |
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 6 month |
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 1 year |
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | pre-op |
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 3 month |
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 6 month |
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 1 year |
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | pre-op |
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 3 month |
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 6 month |
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 1 year |
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | pre-op |
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 3 month |
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 6 month |
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 1 year |
| Number of Participant With Tendon Exposure | Tendon exposure identified clinically. | 6 month |
| Rate of Tendon Exposure | Tendon exposure identified clinically. | 1 year |
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 3 month |
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 6 month |
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 1 year |
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | pre-op |
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 3 month |
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 6 month |
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 1 year |
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 3 month |
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 6 month |
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 1 year |
| Skin Pliability | Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf). | 1 year |
| 6 month |
| Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. | 1 year |
| Graft loss |
|
| Failed to sign consent |
|
| BG001 | Split Thickness Skin Graft (STSG) | reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Vancouver Scar Scale | The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome. | Data not collected | Posted | 1 Year |
|
|
| Primary | Vancouver Scar Scale - Pigmentation | Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome. | Data not collected | Posted | 1 year |
|
|
| Primary | Vancouver Scar Scale - Vascularity | Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | Data not collected | Posted | 1 year |
|
|
| Primary | Vancouver Scar Scale - Pliability | Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome. | Data not collected | Posted | 1 year |
|
|
| Primary | Vancouver Scar Scale - Height | Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | Data not collected | Posted | 1 year |
|
|
| Primary | Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | Pre-op |
|
|
|
| Primary | Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | 3 month |
|
|
|
| Primary | Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | 6 months |
|
|
|
| Primary | Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | Data not recorded. | Posted | 1 year |
|
|
| Primary | Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | pre-op |
|
|
|
| Primary | Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | 3 month |
|
|
|
| Primary | Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | Posted | Mean | Standard Deviation | Lbs | 6 month |
|
|
|
| Primary | Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | Data not collected | Posted | 1 year |
|
|
| Primary | Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | Posted | Mean | Standard Deviation | Lbs | pre-op |
|
|
|
| Primary | Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | Posted | Mean | Standard Deviation | Lbs | 3 month |
|
|
|
| Primary | Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | Posted | Mean | Standard Deviation | Lbs | 6 month |
|
|
|
| Primary | Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | Data not collected | Posted | 1 year |
|
|
| Primary | Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | pre-op |
|
|
|
| Primary | Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | 3 month |
|
|
|
| Primary | Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | 6 month |
|
|
|
| Primary | Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Data not collected | Posted | 1 year |
|
|
| Primary | Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | pre-op |
|
|
|
| Primary | Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | 3 month |
|
|
|
| Primary | Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Posted | Mean | Standard Deviation | degrees | 6 month |
|
|
|
| Primary | Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | Data not collected | Posted | 1 year |
|
|
| Primary | Number of Participant With Tendon Exposure | Tendon exposure identified clinically. | Posted | Number | participants | 6 month |
|
|
|
| Primary | Rate of Tendon Exposure | Tendon exposure identified clinically. | Data not collected | Posted | 1 year |
|
|
| Primary | Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | Data not collected | Posted | 3 month |
|
|
| Primary | Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | Data not collected | Posted | 6 month |
|
|
| Primary | Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | Data not collected | Posted | 1 year |
|
|
| Primary | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | Data not collected | Posted | pre-op |
|
|
| Primary | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | Posted | Mean | Standard Deviation | score on a scale | 3 month |
|
|
|
| Primary | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Primary | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | data not recorded for all subjects | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Primary | Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | data not recorded | Posted | 3 month |
|
|
| Primary | Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | data not recorded | Posted | 6 month |
|
|
| Primary | Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | data not recorded | Posted | 1 year |
|
|
| Primary | Skin Pliability | Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf). | Data not collected | Posted | 1 year |
|
|
| Other Pre-specified | Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 3 month |
|
|
|
| Other Pre-specified | Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Other Pre-specified | Patient Scar Assessment | Total score (20-200). Higher scores denote worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Split Thickness Skin Graft (STSG) | reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG | 1 | 4 | 1 | 4 | 0 | 4 |
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