An interventional study of Topical calcium glycerophosphate lotion in Wound Healing and Scarring, sponsored by AkPharma Inc.. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-12-22.
Sponsored by AkPharma Inc. · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
317 studies on the registry are indexed under Cicatrix; 54 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 260 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →This is the only study on the registry with AkPharma Inc. as lead sponsor.
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Exclusion Criteria:
Other: Topical calcium glycerophosphate lotion
2g once daily for 6 weeks (post-op day 3 thru 42)
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.
Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Op Day: 3 (baseline), 7, 42, 180, 365
The record gives a start of Apr 2008, a primary completion of Oct 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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