The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
TOPCGP-2008
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 22, 2010
CompletedDecember 22, 2010
December 1, 2010
2.5 years
December 20, 2010
December 20, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Secondary Outcomes (4)
Reduction of visible erythema/ inflammation
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Scar minimization or prevention
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Incision/ scar pain and sensitivity
Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Range of motion
Post-Op Day: 3 (baseline), 7, 42, 180, 365
Study Arms (2)
topical calcium glycerophosphate lotion
ACTIVE COMPARATORstandard-of-care
NO INTERVENTIONInterventions
2g once daily for 6 weeks (post-op day 3 thru 42)
Eligibility Criteria
You may qualify if:
- Informed consent must be obtained
- years of age
- Scheduled for bilateral knee replacement surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AkPharma Inc.lead
- Rothman Institute Orthopaedicscollaborator
- Texas Tech University Health Sciences Centercollaborator
- Cyberderm Inc.collaborator
- Bacharach Institute for Rehabilitation, Pomona, NJcollaborator
Study Sites (1)
Rothman Institute Orthopaedics
Egg Harbor, New Jersey, 08234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alvin C. Ong, M.D.
Rothman Institute Orthopaedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 22, 2010
Study Start
April 1, 2008
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
December 22, 2010
Record last verified: 2010-12