The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: Integra plus STSG; Procedure: STSG

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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; Procedure: STSG; 0.012mm STSG
Active Comparator: Split Thickness Skin Graft (STSG); reconstruction as dictated by the protocol. They will either receive 1) a 0	Procedure: STSG; 0.012mm STSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	6 month
Patient Scar Assessment	Total score (20-200). Higher scores denote worse outcomes.	1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joseph Molnar, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): August 18, 2017
• Study Completion (Actual): August 6, 2018

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Wounds; Traumatic Defect
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IRB00031531; CCCWFU 99915A (Other Identifier: Wake Forest University Health Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes