The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Single Blind, Comparative, Controlled Study On The Effects Of Topical Calcium Glycerophosphate On Surgical Wound Healing And Residual Scarring In Bilateral Total Knee Arthroplasty Patients

Conditions
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Wound Healing, Scarring

Intervention / Treatment
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* Other: Topical calcium glycerophosphate lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent must be obtained 45-75 years of age Scheduled for bilateral knee replacement surgery Exclusion Criteria: Employee or immediate family of either AkPharma or employee or immediate family of investigator or site personnel Pregnant or breast feeding Known allergy or hypersensitivity to calcium or phosphorus supplements Diagnosed with type I or type II diabetes mellitus

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical calcium glycerophosphate lotion<br> | Other: Topical calcium glycerophosphate lotion<br>* 2g once daily for 6 weeks (post-op day 3 thru 42)<br>|
| No Intervention: standard-of-care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |