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

Not Applicable

Completed

• Conditions: Wound Healing; Scarring
• Interventions: Other: Topical calcium glycerophosphate lotion

• Registration Number: NCT01264588
• Lead Sponsor: AkPharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2010-10
• Status Verified: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Last Update Submitted: 2010-12-20
• Study First Posted: 2010-12-22
• Last Update Posted: 2010-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical calcium glycerophosphate lotion	Topical calcium glycerophosphate lotion	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Rothman Institute Orthopaedics; 🇺🇸 Egg Harbor Township, New Jersey, United States