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

• Sponsor: AkPharma Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01264588
• Collaborator: Rothman Institute Orthopaedics (Other), Texas Tech University Health Sciences Center (Other), Cyberderm Inc. (Industry), Bacharach Institute for Rehabilitation, Pomona, NJ (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Healing; Scarring	Other: Topical calcium glycerophosphate lotion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Improvement of surgical wound appearance [Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365]

   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

1. Reduction of visible erythema/ inflammation [Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365]

   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.

2. Scar minimization or prevention [Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365]

   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.

3. Incision/ scar pain and sensitivity [Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365]

   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.

4. Range of motion [Post-Op Day: 3 (baseline), 7, 42, 180, 365]

   Range of motion (both flexion and extension) is evaluated using standard goniometric methods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 Inc.
• Bacharach Institute for Rehabilitation, Pomona, NJ

Investigators

• Principal Investigator: Alvin C. Ong, M.D., Rothman Institute Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01264588
• Other Study ID Numbers: TOPCGP-2008
• First Posted: Dec 22, 2010
• Last Update Posted: Dec 22, 2010
• Last Verified: Dec 1, 2010

• Additional relevant MeSH terms: Cicatrix; Wounds and Injuries; Surgical Wound; Calcium

Study Results

No Results Posted as of Dec 22, 2010