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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014