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

February 1, 2010
December 9, 2010
September 2009
November 2010   (final data collection date for primary outcome measure)
To compare epithelialization over time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01061502 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Burns
  • Wound Healing
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061502
XSMP-014
Yes
Andrew Blount, MD, Spectrum Health Blodgett Hospital
Vomaris Innovations
Not Provided
Principal Investigator: Andrew L Blount, MD Blodgett Hospital
Study Director: Richard Wilcox, MD Blodgett Hospital
Vomaris Innovations
December 2010

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