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

NCT02980601 | Terminated Results FDA Device

• 2 other identifiers: IRB00031531CCCWFU 99915A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Traumatic Defect; Chronic Wounds

Outcome Measures

Primary Outcomes (39)

• 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 Outcomes (3)

• Patient Scar Assessment

  3 month

• Patient Scar Assessment

  6 month

• Patient Scar Assessment

  1 year

Study Arms (2)

Integra and a Split Thickness Skin Graft (STSG)

EXPERIMENTAL

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; Procedure: STSG

Split Thickness Skin Graft (STSG)

ACTIVE COMPARATOR

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

Procedure: STSG

Interventions

Integra plus STSG DEVICE

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 and a Split Thickness Skin Graft (STSG)

STSG PROCEDURE

0.012mm STSG

Integra and a Split Thickness Skin Graft (STSG); Split Thickness Skin Graft (STSG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Joseph Molnar
• Organization: Wake Forest Baptist Health

jmolnar@wakehealth.edu

336-716-4171

Study Officials

• Joseph Molnar, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2015
• Primary Completion: August 18, 2017
• Study Completion: August 6, 2018
• Last Updated: May 24, 2019
• Results First Posted: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)