Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Average Grip Strength (lbs) in the operative hand and non-operative hand |
Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds. |
up to 6 months |
|
Primary |
Average Key Pinch Strength (lbs) in the operative hand and non-operative hand |
Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds. |
up to 6 months |
|
Primary |
Average Physician and Patient Rating of Scar Appearance |
Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10. |
up to 6 months |
|
Primary |
Aggregated Brief Michigan Hand Questionnaire results (composite score) |
Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100. |
up to 6 months |
|
Primary |
Average Static Two Point Discrimination (mm) |
Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters. |
up to 6 months |
|
Secondary |
Number of patients with complete flap loss |
Number of patients with complete flap loss as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients with partial flap loss |
Number of patients with partial flap loss as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients reporting cold intolerance |
Number of patients reporting cold intolerance in the operative and non-operative extremity as assessed by patient's response to questioning them about feeling cold intolerance. |
up to 6 months |
|
Secondary |
Number of patients reporting neuropathy |
Number of patients reporting cold intolerance as assessed by patient's response to questioning them about feeling neuropathy |
up to 6 months |
|
Secondary |
Number of patients with postoperative hematoma at donor site |
Number of patients with postoperative hematoma at donor site, as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients with postoperative cellulitis at donor site |
Number of patients with postoperative cellulitis at donor site as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients with postoperative hematoma at recipient site |
Number of patient with postoperative hematoma at recipient site, as assessed by chart review |
up to 6 months |
|
Secondary |
Number of patient with postoperative infection at recipient site |
Number of patient with postoperative infection at recipient site, as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients experiencing mortality |
Number of patients experiencing mortality, as assessed by chart review. |
up to 6 months |
|
Secondary |
Number of patients with donor site dehiscence |
Number of patients with donor site dehiscence, as assessed by chart review |
up to 6 months |
|
Secondary |
Number of patients with partial skin graft non-take |
Number of patients with partial skin graft non-take, as assessed by chart review |
up to 6 months |
|
Secondary |
Number of patients with complete skin graft non-take |
Number of patients with complete skin graft non-take, as assessed by chart review |
up to 6 months |
|