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

This study has been completed.
Sponsor:
Collaborators:
Rothman Institute Orthopaedics
Texas Tech University Health Sciences Center
cyberDERM Clinical Studies
Bacharach Institute for Rehabilitation
Information provided by:
AkPharma Inc.
ClinicalTrials.gov Identifier:
NCT01264588
First received: December 20, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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


Condition Intervention
Wound Healing
Scarring
 Other: Topical calcium glycerophosphate lotion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Scars
U.S. FDA Resources

Further study details as provided by AkPharma Inc.:

Primary Outcome Measures:
  • Improvement of surgical wound appearance [ Time Frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Reduction of visible erythema/ inflammation [ Time Frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Range of motion (both flexion and extension) is evaluated using standard goniometric methods.


Enrollment: 20
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264588

Locations
United States, New Jersey
Rothman Institute Orthopaedics
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
AkPharma Inc.
Rothman Institute Orthopaedics
Texas Tech University Health Sciences Center
cyberDERM Clinical Studies
Bacharach Institute for Rehabilitation
Investigators
Principal Investigator: Alvin C. Ong, M.D. Rothman Institute Orthopaedics
  More Information

No publications provided

Responsible Party: Alvin C. Ong, M.D., Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01264588     History of Changes
Other Study ID Numbers: TOPCGP-2008
Study First Received: December 20, 2010
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Calcium, Dietary
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013