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

Overview

The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: October 2010

Interventions

  • Other: Topical calcium glycerophosphate lotion
    • 2g once daily for 6 weeks (post-op day 3 thru 42)

Arms, Groups and Cohorts

  • Active Comparator: topical calcium glycerophosphate lotion
  • No Intervention: standard-of-care

Clinical Trial Outcome Measures

Primary Measures

  • Improvement of surgical wound appearance
    • Time Frame: 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 Measures

  • Reduction of visible erythema/ inflammation
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Post-Op Day: 3 (baseline), 7, 42, 180, 365
    • Range of motion (both flexion and extension) is evaluated using standard goniometric methods.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AkPharma Inc.
  • Collaborator
    • Rothman Institute Orthopaedics
  • Provider of Information About this Clinical Study
    • Alvin C. Ong, M.D., Rothman Institute Orthopaedics
  • Overall Official(s)
    • Alvin C. Ong, M.D., Principal Investigator, Rothman Institute Orthopaedics

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