Back to resultsUtility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Restrata Graft
Standard of Care Skin Graft
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
- Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Exclusion Criteria:
- Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
- Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
- Morbid obesity (BMI >40).
- Inability to maintain wrist immobilization for full planned period.
- Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
- Other conditions felt to significantly impair wound healing per surgeon discretion
Sites / Locations
- Nebraska Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A - Standard of Care
B - Restrata Graft
Arm Description
Outcomes
Primary Outcome Measures
Tendon exposure
Tendon exposure at four weeks post-operatively (Yes/No).
Percentage of surface area
Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.
Secondary Outcome Measures
Full Information
NCT ID
NCT04880603
First Posted
May 5, 2021
Last Updated
May 9, 2022
Sponsor
Nebraska Methodist Health System
Collaborators
Acera Surgical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04880603
Brief Title
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Official Title
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Investigators no longer interested in pursuing
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nebraska Methodist Health System
Collaborators
Acera Surgical, Inc.
4. Oversight
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
5. Study Description
Brief Summary
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - Standard of Care
Arm Type
Active Comparator
Arm Title
B - Restrata Graft
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Restrata Graft
Intervention Description
Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care Skin Graft
Intervention Description
Standard of Care Skin Graft
Primary Outcome Measure Information:
Title
Tendon exposure
Description
Tendon exposure at four weeks post-operatively (Yes/No).
Time Frame
4 weeks post-operation
Title
Percentage of surface area
Description
Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.
Time Frame
4 weeks post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Exclusion Criteria:
Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
Morbid obesity (BMI >40).
Inability to maintain wrist immobilization for full planned period.
Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
Other conditions felt to significantly impair wound healing per surgeon discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lindau, MD
Organizational Affiliation
Nebraska Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
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