Head and Neck Cancer
Conditions
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.
Interventions
DEVICERestrata Graft
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.
PROCEDUREStandard of Care Skin Graft
Standard of Care Skin Graft
Sponsors
Acera Surgical, Inc.
Nebraska Methodist Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendon exposure | 4 weeks post-operation | Tendon exposure at four weeks post-operatively (Yes/No). |
| Percentage of surface area | 4 weeks post operation | Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively. |
Countries
United States
Outcome results
None listed