The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring (TOPCGP-2008)

December 20, 2010 updated by: AkPharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Institute Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
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.
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
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.
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
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.
Post-Op Day: 3 (baseline), 7, 42, 180, 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AkPharma Inc.

Collaborators

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

Investigators

  • Principal Investigator: Alvin C. Ong, M.D., Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPCGP-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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