Scarring, Wound Healing
Conditions
Brief summary
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
Interventions
OTHERTopical calcium glycerophosphate lotion
2g once daily for 6 weeks (post-op day 3 thru 42)
Sponsors
Rothman Institute Orthopaedics
Texas Tech University Health Sciences Center
Cyberderm Inc.
Bacharach Institute for Rehabilitation, Pomona, NJ
AkPharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of surgical wound appearance | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of visible erythema/ inflammation | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 | 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. |
| Scar minimization or prevention | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 | 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. |
| Incision/ scar pain and sensitivity | Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 | 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. |
| Range of motion | Post-Op Day: 3 (baseline), 7, 42, 180, 365 | Range of motion (both flexion and extension) is evaluated using standard goniometric methods. |
Countries
United States
Outcome results
None listed