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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
  Purpose

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 Intervention Phase
Burns
Wound Healing
 Device: Procellera (Bioelectric Wound Dressing)
Device: Opsite (Transparent Adhesive Dressing)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Vomaris Innovations:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew Blount, MD, Spectrum Health Blodgett Hospital
ClinicalTrials.gov Identifier: NCT01061502     History of Changes
Other Study ID Numbers: XSMP-014
Study First Received: February 1, 2010
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013