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| Name | Class |
|---|---|
| Rothman Institute Orthopaedics | OTHER |
| Texas Tech University Health Sciences Center | OTHER |
| Cyberderm Inc. | INDUSTRY |
| Bacharach Institute for Rehabilitation, Pomona, NJ |
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The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical calcium glycerophosphate lotion | Active Comparator |
| |
| standard-of-care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical calcium glycerophosphate lotion | Other | 2g once daily for 6 weeks (post-op day 3 thru 42) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of surgical wound appearance | Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in the time required for wound closure and/ or scar minimization between treated and untreated groups. | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of visible erythema/ inflammation | Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in reduction of visible erythema/ inflammation between treated and untreated groups. | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvin C. Ong, M.D. | Rothman Institute Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute Orthopaedics | Egg Harbor | New Jersey | 08234 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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| Scar minimization or prevention | Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in scar appearance between treated and untreated groups. | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 |
| Incision/ scar pain and sensitivity | Subjects are asked to rate their pain at the site of incision for each knee, using a scale of 0 (no pain) to 10 (excruciating pain). The pain evaluations are recorded on a pain diary sheet provided at each time point. | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 |
| Range of motion | Range of motion (both flexion and extension) is evaluated using standard goniometric methods. | Post-Op Day: 3 (baseline), 7, 42, 180, 365 |