Wound Heal
Conditions
Brief summary
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
Interventions
DEVICERestrata
Restrata is a sterile, single use device intended for use in local management of wounds
Sponsors
Acera Surgical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. 2. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Exclusion criteria
1. 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). 2. Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery. 3. Morbid obesity (BMI \>40). 4. Inability to maintain wrist immobilization for full planned period. 5. Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight). 6. Other conditions felt to significantly impair wound healing per surgeon discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendon Exposure | 4 weeks post-operatively | Percentage of participants with tendon exposure |
| Surface Area of Split-thickness Skin Graft Incorporation | 4 weeks post-operatively | Percentage of surface area of split-thickness skin graft incorporation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restrata With a Split-thickness Skin Graft Restrata: Restrata is a sterile, single use device intended for use in local management of wounds | 3 |
| Split-thickness Skin Graft Alone Split-thickness skin graft without Restrata | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Restrata With a Split-thickness Skin Graft | Split-thickness Skin Graft Alone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 4.5 | 49.5 years STANDARD_DEVIATION 5.5 | 61.4 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 1 / 3 | 0 / 2 |
Outcome results
Primary
Surface Area of Split-thickness Skin Graft Incorporation
Percentage of surface area of split-thickness skin graft incorporation
Time frame: 4 weeks post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Restrata With a Split-thickness Skin Graft | Surface Area of Split-thickness Skin Graft Incorporation | 90% graft take | 0 Participants |
| Restrata With a Split-thickness Skin Graft | Surface Area of Split-thickness Skin Graft Incorporation | % not assessed due to study termination | 3 Participants |
| Split-thickness Skin Graft Alone | Surface Area of Split-thickness Skin Graft Incorporation | 90% graft take | 1 Participants |
| Split-thickness Skin Graft Alone | Surface Area of Split-thickness Skin Graft Incorporation | % not assessed due to study termination | 1 Participants |
Primary
Tendon Exposure
Percentage of participants with tendon exposure
Time frame: 4 weeks post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Restrata With a Split-thickness Skin Graft | Tendon Exposure | % of patients with tendon exposure at 4 weeks | 1 Participants |
| Restrata With a Split-thickness Skin Graft | Tendon Exposure | % patients lost to follow up prior to 4 weeks | 1 Participants |
| Restrata With a Split-thickness Skin Graft | Tendon Exposure | % of patients with tendon coverage at 4 weeks | 1 Participants |
| Split-thickness Skin Graft Alone | Tendon Exposure | % of patients with tendon exposure at 4 weeks | 0 Participants |
| Split-thickness Skin Graft Alone | Tendon Exposure | % patients lost to follow up prior to 4 weeks | 0 Participants |
| Split-thickness Skin Graft Alone | Tendon Exposure | % of patients with tendon coverage at 4 weeks | 2 Participants |