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

AkPharma Inc.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Wound Healing Scarring

Interventions

Topical calcium glycerophosphate lotionOTHER

2g once daily for 6 weeks (post-op day 3 thru 42)

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Rothman Institute Orthopaedics

Egg Harbor, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365

Secondary Outcomes

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.

Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365

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.

Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365

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.

Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365

Range of motion

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

Time frame: Post-Op Day: 3 (baseline), 7, 42, 180, 365

Data from ClinicalTrials.gov

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