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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01061502
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Burns Wound Healing Device: Procellera (Bioelectric Wound Dressing) Device: Opsite (Transparent Adhesive Dressing) Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
Study Start Date : September 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Procellera Wound Dressing
Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed
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
Active Comparator: Opsite Transparent Adhesive Dressing
Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed
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


Outcome Measures

Primary Outcome Measures :
  1. To compare epithelialization over time [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To compare patient reported perception of pain [ Time Frame: 3 months ]
  2. To compare scarring [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061502


Locations
United States, Michigan
Blodgett Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Vomaris Innovations
Investigators
Principal Investigator: Andrew L Blount, MD Blodgett Hospital
Study Director: Richard Wilcox, MD Blodgett Hospital
More Information

Responsible Party: Andrew Blount, MD, Spectrum Health Blodgett Hospital
ClinicalTrials.gov Identifier: NCT01061502     History of Changes
Other Study ID Numbers: XSMP-014
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by Vomaris Innovations:
Burns
Wounds and Injuries
Skin Grafts, Bioelectric
Grafting, skin

Additional relevant MeSH terms:
Wounds and Injuries