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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02980601
• Other study ID #: IRB00031531
• Secondary ID: CCCWFU 99915A
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 6, 2018

Study information

• Verified date: May 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 6, 2018
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Scar Assessment	Total score (20-200). Higher scores denote worse outcomes.	3 month
Other	Patient Scar Assessment	Total score (20-200). Higher scores denote worse outcomes.	6 month
Other	Patient Scar Assessment	Total score (20-200). Higher scores denote worse outcomes.	1 year
Primary	Number of Participants With Skin Graft Necrosis.	Number of participants with skin graft necrosis.	1 year
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.	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.	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.	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.	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.	1 year
Primary	Hand Strength -Lateral Pinch	Functional outcomes will be measured by using strength dynamometers.	Pre-op
Primary	Hand Strength -Lateral Pinch	Functional outcomes will be measured by using strength dynamometers.	3 month
Primary	Hand Strength -Lateral Pinch	Functional outcomes will be measured by using strength dynamometers.	6 months
Primary	Hand Strength -Lateral Pinch	Functional outcomes will be measured by using strength dynamometers.	1 year
Primary	Hand Strength - Grip	Functional outcomes will be measured by using strength dynamometers.	pre-op
Primary	Hand Strength - Grip	Functional outcomes will be measured by using strength dynamometers.	3 month
Primary	Hand Strength - Grip	Functional outcomes will be measured by using strength dynamometers.	6 month
Primary	Hand Strength - Grip	Functional outcomes will be measured by using strength dynamometers.	1 year
Primary	Hand Strength- Pincer	Functional outcomes will be measured by using strength dynamometers	pre-op
Primary	Hand Strength- Pincer	Functional outcomes will be measured by using strength dynamometers	3 month
Primary	Hand Strength- Pincer	Functional outcomes will be measured by using strength dynamometers	6 month
Primary	Hand Strength- Pincer	Functional outcomes will be measured by using strength dynamometers	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	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	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	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	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	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	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	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	1 year
Primary	Number of Participant With Tendon Exposure	Tendon exposure identified clinically.	6 month
Primary	Rate of Tendon Exposure	Tendon exposure identified clinically.	1 year
Primary	Patient Scar Assessment- Paresthesia	Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes	3 month
Primary	Patient Scar Assessment- Paresthesia	Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes	6 month
Primary	Patient Scar Assessment- Paresthesia	Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes	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	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	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	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	1 year
Primary	Percent of Wound Contracture	Planimetry Software will be used to measure and determine percentage of wound contracture	3 month
Primary	Percent of Wound Contracture	Planimetry Software will be used to measure and determine percentage of wound contracture	6 month
Primary	Percent of Wound Contracture	Planimetry Software will be used to measure and determine percentage of wound contracture	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).	1 year