Back to resultsThe Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring (TOPCGP-2008)
Primary Purpose
Wound Healing, Scarring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical calcium glycerophosphate lotion
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Healing
Eligibility 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
Sites / Locations
- Rothman Institute Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
topical calcium glycerophosphate lotion
standard-of-care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Range of motion
Range of motion (both flexion and extension) is evaluated using standard goniometric methods.
Full Information
NCT ID
NCT01264588
First Posted
December 20, 2010
Last Updated
December 20, 2010
Sponsor
AkPharma Inc.
Collaborators
Rothman Institute Orthopaedics, Texas Tech University Health Sciences Center, Cyberderm Inc., Bacharach Institute for Rehabilitation, Pomona, NJ
1. Study Identification
Unique Protocol Identification Number
NCT01264588
Brief Title
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
Acronym
TOPCGP-2008
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AkPharma Inc.
Collaborators
Rothman Institute Orthopaedics, Texas Tech University Health Sciences Center, Cyberderm Inc., Bacharach Institute for Rehabilitation, Pomona, NJ
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Scarring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
topical calcium glycerophosphate lotion
Arm Type
Active Comparator
Arm Title
standard-of-care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Topical calcium glycerophosphate lotion
Intervention Description
2g once daily for 6 weeks (post-op day 3 thru 42)
Primary Outcome Measure Information:
Title
Improvement of surgical wound appearance
Description
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
Secondary Outcome Measure Information:
Title
Reduction of visible erythema/ inflammation
Description
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
Title
Scar minimization or prevention
Description
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
Title
Incision/ scar pain and sensitivity
Description
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
Title
Range of motion
Description
Range of motion (both flexion and extension) is evaluated using standard goniometric methods.
Time Frame
Post-Op Day: 3 (baseline), 7, 42, 180, 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvin C. Ong, M.D.
Organizational Affiliation
Rothman Institute Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Institute Orthopaedics
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
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