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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
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
0.012mm STSG
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Number of Participants With Skin Graft Necrosis.
Number of participants with skin graft necrosis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: Pre-op
Hand Strength -Lateral Pinch
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Functional outcomes will be measured by using strength dynamometers.
Time frame: 3 month
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: 6 months
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Time frame: 1 year
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: pre-op
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 3 month
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 6 month
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Time frame: 1 year
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: pre-op
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 3 month
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 6 month
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year
Number of Participant With Tendon Exposure
Tendon exposure identified clinically.
Time frame: 6 month
Rate of Tendon Exposure
Tendon exposure identified clinically.
Time frame: 1 year
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 3 month
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 6 month
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 3 month
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 6 month
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Time frame: 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).
Time frame: 1 year