Head and Neck Cancer
Conditions
Keywords
Traumatic Defect, Chronic Wounds
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntegra 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
PROCEDURESTSG
0.012mm STSG
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction. * Have had a distal, anterograde fasciocutaneous flap * Age ≥ 18 years * Ability to understand and the willingness to sign an IRB-approved informed consent document. * Smokers and tobacco users will be included in this study
Exclusion criteria
* Subjects who have had an osteocutaneous or musculocutaneous flap. * Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a reverse radial forearm flap * Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Pliability | 1 year | Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf). |
| Wrist Range of Motion- Flexion | pre-op | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension |
| Number of Participants With Skin Graft Necrosis. | 1 year | Number of participants with skin graft necrosis. |
| Vancouver Scar Scale | 1 Year | 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. |
| Vancouver Scar Scale - Pigmentation | 1 year | Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome. |
| Vancouver Scar Scale - Vascularity | 1 year | Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. |
| Vancouver Scar Scale - Pliability | 1 year | Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome. |
| Vancouver Scar Scale - Height | 1 year | Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. |
| Hand Strength -Lateral Pinch | Pre-op | Functional outcomes will be measured by using strength dynamometers. |
| Hand Strength - Grip | pre-op | Functional outcomes will be measured by using strength dynamometers. |
| Hand Strength- Pincer | pre-op | Functional outcomes will be measured by using strength dynamometers |
| Wrist Range of Motion- Extension | pre-op | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension |
| Number of Participant With Tendon Exposure | 6 month | Tendon exposure identified clinically. |
| Rate of Tendon Exposure | 1 year | Tendon exposure identified clinically. |
| Patient Scar Assessment- Paresthesia | 3 month | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes |
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | pre-op | 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 |
| Percent of Wound Contracture | 3 month | Planimetry Software will be used to measure and determine percentage of wound contracture |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Scar Assessment | 3 month | Total score (20-200). Higher scores denote worse outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Split Thickness Skin Graft (STSG) reconstruction as dictated by the protocol. They will either receive 1) a 0
STSG: 0.012mm STSG | 4 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Failed to sign consent | 2 | 0 |
| Overall Study | Graft loss | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Integra and a Split Thickness Skin Graft (STSG) | Split Thickness Skin Graft (STSG) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 4 |
| other Total, other adverse events | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 1 / 4 |
Outcome results
Primary
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 58.14285714 Lbs | Standard Deviation 22.94358654 |
| Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 66.4 Lbs | Standard Deviation 21.81375713 |
Primary
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 72.4 Lbs | Standard Deviation 19.82523644 |
| Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 79.25 Lbs | Standard Deviation 16.02146997 |
Primary
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 1 year
Population: Data not collected
Primary
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 66.4 Lbs | Standard Deviation 25.49195952 |
| Split Thickness Skin Graft (STSG) | Hand Strength - Grip | 81.66666667 Lbs | Standard Deviation 16.49915823 |
Primary
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 15.8 Lbs | Standard Deviation 4.833218389 |
| Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 19.33333333 Lbs | Standard Deviation 2.494438258 |
Primary
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: Pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 19.4 Lbs | Standard Deviation 4.176123 |
| Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 21.25 Lbs | Standard Deviation 2.165064 |
Primary
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: 1 year
Population: Data not recorded.
Primary
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 14.57142857 Lbs | Standard Deviation 4.655477353 |
| Split Thickness Skin Graft (STSG) | Hand Strength -Lateral Pinch | 16.8 Lbs | Standard Deviation 3.059411708 |
Primary
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 13.4 Lbs | Standard Deviation 4.079215611 |
| Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 16 Lbs | Standard Deviation 3.265986324 |
Primary
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 1 year
Population: Data not collected
Primary
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 13.4 Lbs | Standard Deviation 4.176122604 |
| Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 14.75 Lbs | Standard Deviation 3.561951712 |
Primary
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 11 Lbs | Standard Deviation 5.318431563 |
| Split Thickness Skin Graft (STSG) | Hand Strength- Pincer | 12.2 Lbs | Standard Deviation 5.306599665 |
Primary
Number of Participants With Skin Graft Necrosis.
Number of participants with skin graft necrosis.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Number of Participants With Skin Graft Necrosis. | 2 participants |
| Split Thickness Skin Graft (STSG) | Number of Participants With Skin Graft Necrosis. | 1 participants |
Primary
Number of Participant With Tendon Exposure
Tendon exposure identified clinically.
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Number of Participant With Tendon Exposure | 2 participants |
| Split Thickness Skin Graft (STSG) | Number of Participant With Tendon Exposure | 1 participants |
Primary
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 1 year
Population: Data not collected
Primary
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 6 month
Population: Data not collected
Primary
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 3 month
Population: Data not collected
Primary
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 3 month
Population: data not recorded
Primary
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 1 year
Population: data not recorded
Primary
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 6 month
Population: data not recorded
Primary
Rate of Tendon Exposure
Tendon exposure identified clinically.
Time frame: 1 year
Population: Data not collected
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).
Time frame: 1 year
Population: Data not collected
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
Time frame: pre-op
Population: Data not collected
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
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | 27.43333333 score on a scale | Standard Deviation 18.01894065 |
| Split Thickness Skin Graft (STSG) | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | 29.525 score on a scale | Standard Deviation 23.13118836 |
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
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | -3.636363636 score on a scale | Standard Deviation 26.31264662 |
| Split Thickness Skin Graft (STSG) | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | -9.090909091 score on a scale | Standard Deviation 16.62356686 |
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
Time frame: 1 year
Population: data not recorded for all subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | 5 score on a scale | Standard Deviation 11.056672193748 |
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.
Time frame: 1 Year
Population: Data not collected
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.
Time frame: 1 year
Population: Data not collected
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.
Time frame: 1 year
Population: Data not collected
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.
Time frame: 1 year
Population: Data not collected
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.
Time frame: 1 year
Population: Data not collected
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
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 59.4 degrees | Standard Deviation 21.10544953 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 70 degrees | Standard Deviation 8.498365856 |
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
Time frame: 1 year
Population: Data not collected
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
Time frame: pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 57.33333333 degrees | Standard Deviation 9.689627902 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 49.66666667 degrees | Standard Deviation 7.758060325 |
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
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 45 degrees | Standard Deviation 15.58387445 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Extension | 47.5 degrees | Standard Deviation 13.78404875 |
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
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 59.8 degrees | Standard Deviation 11.66876172 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 68.333333 degrees | Standard Deviation 6.236095645 |
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
Time frame: 1 year
Population: Data not collected
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
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 66.42857143 degrees | Standard Deviation 13.55261854 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 69 degrees | Standard Deviation 12 |
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
Time frame: pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 72.83333333 degrees | Standard Deviation 15.44254585 |
| Split Thickness Skin Graft (STSG) | Wrist Range of Motion- Flexion | 68 degrees | Standard Deviation 16.02146997 |
Other Pre-specified
Patient Scar Assessment
Total score (20-200). Higher scores denote worse outcomes.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 86.14285714 score on a scale | Standard Deviation 26.03529786 |
| Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 82.25 score on a scale | Standard Deviation 27.72521416 |
Other Pre-specified
Patient Scar Assessment
Total score (20-200). Higher scores denote worse outcomes.
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 89.8 score on a scale | Standard Deviation 78.170071 |
| Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 65.5 score on a scale | Standard Deviation 20.5 |
Other Pre-specified
Patient Scar Assessment
Total score (20-200). Higher scores denote worse outcomes.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 24.5 score on a scale | Standard Deviation 3.5 |
| Split Thickness Skin Graft (STSG) | Patient Scar Assessment | 28 score on a scale | Standard Deviation 0 |