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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01264588
Other study ID # TOPCGP-2008
Secondary ID
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


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
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