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Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

NCT ID: NCT01061502

Last Updated: 2010-12-10

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

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.

Detailed Description

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Conditions

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Burns Wound Healing

Keywords

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Burns Wounds and Injuries Skin Grafts, Bioelectric Grafting, skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Procellera Wound Dressing

Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed

Group Type EXPERIMENTAL

Procellera (Bioelectric Wound Dressing)

Intervention Type DEVICE

Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed

Opsite Transparent Adhesive Dressing

Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed

Group Type ACTIVE_COMPARATOR

Opsite (Transparent Adhesive Dressing)

Intervention Type DEVICE

Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.

Interventions

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Procellera (Bioelectric Wound Dressing)

Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed

Intervention Type DEVICE

Opsite (Transparent Adhesive Dressing)

Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.

Intervention Type DEVICE

Other Intervention Names

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Procellera PROSIT Procellera Wound Dressing Procellera Device Opsite Dressing

Eligibility Criteria

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Inclusion Criteria

* Wounds resulting from skin graft
* Split thickness wound
* Wound size greater than 2x2 cm
* Wounds must be ≥5 cm away from all other wounds
* 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
* Peripheral vascular occlusive disease
* Collagen vascular disease
* Connective tissue disease
* 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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Spectrum Health Blodgett Hospital

Principal Investigators

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Andrew L Blount, MD

Role: PRINCIPAL_INVESTIGATOR

Blodgett Hospital

Richard Wilcox, MD

Role: STUDY_DIRECTOR

Blodgett Hospital

Locations

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Blodgett Hospital

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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XSMP-014

Identifier Type: -

Identifier Source: org_study_id