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OpenTrials
Completed

NCT Number: NCT01004055

Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.

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Key information

Conditions

Wound Healing Infections Wound Infection Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheftel Associates Dermatology, LLC, Oro Valley, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
  • Wound size greater than 1x1cm
  • Wound must be ≥5 cm away from all other wounds
  • Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
  • 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
  • Collagen vascular disease
  • Diabetes
  • Venous stasis ulcers
  • Participant undergoing active cancer chemotherapy
  • Chronic steroid use
  • Decision impairment

Treatment and study plan

Procellera™ Antimicrobial Wound Dressing

Device

Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed

Other names: PROCELLERA™, PROSIT™, Bioelectric Wound Dressing

ACTICOAT™ Antimicrobial Barrier Dressing

Drug

Dressing changes every 2-3 days, more frequently if needed

Other names: ACTICOAT™

Mepilex® Ag Silver Foam Dressing

Drug

Dressing changes every 2-3 days, more frequently if needed

Other names: Mepilex® Ag

Primary outcomes

  1. Wound healing over time

    Time frame: July 2008-October 2009

Secondary outcomes

  1. Comparing three FDA cleared products for pain reduction and incidence of infection

    Time frame: July 2008-October 2009

Sponsors and collaborators

Lead sponsor

Vomaris Innovations

Industry

Registry information

Official study title

Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 29, 2009
Registry last updated
Oct 29, 2009

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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