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

This study has been completed.

Sponsor:

Information provided by:

Vomaris Innovations

ClinicalTrials.gov Identifier:

NCT01061502

First received: February 1, 2010

Last updated: December 9, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2010

Last Updated Date

December 9, 2010

Start Date ^ICMJE

September 2009

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare epithelialization over time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01061502 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare patient reported perception of pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
To compare scarring [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Burns
Wound Healing

Intervention ^ICMJE

Device: Procellera (Bioelectric Wound Dressing)
Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed
Other Names:
- Procellera
- PROSIT
- Procellera Wound Dressing
- Procellera Device
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.

Other Name: Opsite Dressing

Study Arm (s)

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

Intervention: Device: Procellera (Bioelectric Wound Dressing)
Active Comparator: Opsite Transparent Adhesive Dressing
Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed

Intervention: Device: Opsite (Transparent Adhesive Dressing)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01061502

Other Study ID Numbers ^ICMJE

XSMP-014

Has Data Monitoring Committee

Yes

Responsible Party

Andrew Blount, MD, Spectrum Health Blodgett Hospital

Study Sponsor ^ICMJE

Vomaris Innovations

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Andrew L Blount, MD	Blodgett Hospital
Study Director:	Richard Wilcox, MD	Blodgett Hospital

Information Provided By

Vomaris Innovations

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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