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

NCT ID: NCT01264588

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Wound Healing Scarring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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topical calcium glycerophosphate lotion

Group Type ACTIVE_COMPARATOR

Topical calcium glycerophosphate lotion

Intervention Type OTHER

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

standard-of-care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical calcium glycerophosphate lotion

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role collaborator

Cyberderm Inc.

INDUSTRY

Sponsor Role collaborator

Bacharach Institute for Rehabilitation, Pomona, NJ

OTHER

Sponsor Role collaborator

AkPharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Rothman Institute Orthopaedics

Principal Investigators

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Alvin C. Ong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute Orthopaedics

Locations

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Rothman Institute Orthopaedics

Egg Harbor, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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TOPCGP-2008

Identifier Type: -

Identifier Source: org_study_id