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Completed

NCT Number: NCT01061502

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

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.

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Key information

Conditions

Burns Wound Healing Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Blodgett Hospital

Grand Rapids, Michigan, 49503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procellera (Bioelectric Wound Dressing)

Device

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

Opsite (Transparent Adhesive Dressing)

Device

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 names: Opsite Dressing

Primary outcomes

  1. To compare epithelialization over time

    Time frame: 3 months

Secondary outcomes

  1. To compare patient reported perception of pain

    Time frame: 3 months

  2. To compare scarring

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Vomaris Innovations

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2010
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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