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

Wound Healing Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264588
• Other study ID #: TOPCGP-2008
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: December 20, 2010
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: AkPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cicatrix
• Scarring
• Wound Healing

Intervention

Other:
• Topical calcium glycerophosphate lotion
2g once daily for 6 weeks (post-op day 3 thru 42)

Locations

Country	Name	City	State
United States	Rothman Institute Orthopaedics	Egg Harbor Township	New Jersey

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365	No
Secondary	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.	Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365	No
Secondary	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.	Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365	No
Secondary	Range of motion	Range of motion (both flexion and extension) is evaluated using standard goniometric methods.	Post-Op Day: 3 (baseline), 7, 42, 180, 365	No