Wounds and Injuries

All Conditions

Neoplasms

Rare Diseases

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

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.

reconstruction as dictated by the protocol. They will either receive 1) a 0

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

STSG

Joseph Molnar, MD, PhD

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.

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

Total score (20-200). Higher scores denote worse outcomes.

Number of participants with skin graft necrosis.

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.

Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.

Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.

Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.

Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.

Functional outcomes will be measured by using strength dynamometers.

Functional outcomes will be measured by using strength dynamometers

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes

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

Planimetry Software will be used to measure and determine percentage of wound contracture

Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).

Wake Forest University Health Sciences

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

Integra and a Split Thickness Skin Graft (STSG)

reconstruction as dictated by the protocol. They will either receive 1) a 0

STSG: 0.012mm STSG

Split Thickness Skin Graft (STSG)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Joseph Molnar

Number of Participants With Skin Graft Necrosis.

Vancouver Scar Scale

Vancouver Scar Scale - Pigmentation

Vancouver Scar Scale - Vascularity

Vancouver Scar Scale - Pliability

Vancouver Scar Scale - Height

Hand Strength -Lateral Pinch

Hand Strength - Grip

Hand Strength- Pincer

Wrist Range of Motion- Flexion

Wrist Range of Motion- Extension

Number of Participant With Tendon Exposure

Rate of Tendon Exposure

Patient Scar Assessment- Paresthesia

The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)

Percent of Wound Contracture

Skin Pliability

Patient Scar Assessment

Overall Study

Precancerous Conditions

Integra® is a bilayer wound matrix made out of bovine tissue.

DermACELL® is a bilayer wound matrix made out of human tissue.

DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.

DermACELL®

Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.

Integra®

Christopher Attinger, MD

Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.

This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.

Photographs are submitted and evaluated by a blind, independent assessor.

Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix

A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix

The percent of split thickness skin graft (autograft or allograft) take for a wound that receives DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.

Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.

The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect	NCT02980601	Head and Neck C...	Integra plus ST... STSG	18 Years -	Wake Forest University Health Sciences
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect	NCT02980601	Head and Neck C...	Integra plus ST... STSG	18 Years -	Wake Forest University Health Sciences
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix	NCT03285698	Wounds Chronic Wounds Nonmalignant Co...	DermACELL® Integra®	18 Years - 90 Years	Georgetown University
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect	NCT02980601	Head and Neck C...	Integra plus ST... STSG	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for chronic wounds