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Completed

NCT Number: NCT01264588

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

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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Key information

Conditions

Wound Healing Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scarring

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute Orthopaedics

Egg Harbor, New Jersey, 08234, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical calcium glycerophosphate lotion

Other

2g once daily for 6 weeks (post-op day 3 thru 42)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

AkPharma Inc.

Industry

Collaborators

  • Bacharach Institute for Rehabilitation, Pomona, NJ
  • Cyberderm Inc.
  • Rothman Institute Orthopaedics
  • Texas Tech University Health Sciences Center

Registry information

Official study title

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

Acronym: TOPCGP-2008

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2010
Registry last updated
Dec 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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