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Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

NCT ID: NCT01004055

Last Updated: 2009-10-29

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

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.

Detailed Description

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Conditions

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Wound Healing Wound Infection

Keywords

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Wound Skin lesion Antimicrobial Bioelectric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Procellera™ Wound Dressing

Group Type EXPERIMENTAL

Procellera™ Antimicrobial Wound Dressing

Intervention Type DEVICE

Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed

ACTICOAT™

Group Type ACTIVE_COMPARATOR

ACTICOAT™ Antimicrobial Barrier Dressing

Intervention Type DRUG

Dressing changes every 2-3 days, more frequently if needed

Mepilex® Ag

Group Type ACTIVE_COMPARATOR

Mepilex® Ag Silver Foam Dressing

Intervention Type DRUG

Dressing changes every 2-3 days, more frequently if needed

Interventions

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Procellera™ Antimicrobial Wound Dressing

Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed

Intervention Type DEVICE

ACTICOAT™ Antimicrobial Barrier Dressing

Dressing changes every 2-3 days, more frequently if needed

Intervention Type DRUG

Mepilex® Ag Silver Foam Dressing

Dressing changes every 2-3 days, more frequently if needed

Intervention Type DRUG

Other Intervention Names

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PROCELLERA™, PROSIT™, Bioelectric Wound Dressing ACTICOAT™ Mepilex® Ag

Eligibility Criteria

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Inclusion Criteria

* If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
* Wound size greater than 1x1cm
* Wound must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Collagen vascular disease
* Diabetes
* Venous stasis ulcers
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vomaris Innovations

INDUSTRY

Sponsor Role lead

Responsible Party

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Sheftel Associates Dermatology, LLC

Principal Investigators

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Scott N Sheftel, MD

Role: PRINCIPAL_INVESTIGATOR

Sheftel Associates Dermatology, LLC

Locations

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Sheftel Associates Dermatology, LLC

Oro Valley, Arizona, United States

Site Status

Sheftel Associates Dermatology, LLC

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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XSMP-011

Identifier Type: -

Identifier Source: org_study_id