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OpenTrials
Completed

NCT Number: NCT00816101

Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.

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Key information

Conditions

Acute Wounds

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheftel Associates Dermatology

Tucson, Arizona, 85718, United States

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 1x1 cm
  • Wounds 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
  • Peripheral vascular occlusive disease
  • Collagen vascular disease
  • Connective tissue disease
  • Diabetes
  • Venous stasis ulcers
  • Participant undergoing active cancer chemotherapy
  • Chronic steroid use
  • Decision impairment

Treatment and study plan

Procellera™ Antimicrobial Dressing

Other

Dressing indicated for partial and full-thickness wounds.

Other names: PROCELLERA™, Prosit™ Antimicrobial Dressing, Prosit™ Technology

Mepilex® Border Lite

Other

Self-adherent foam dressing

Other names: Mepilex®

Adhesive Bandage

Device

Adhesive bandage

Other names: Band-Aid® Adhesive Bandage

Primary outcomes

  1. Number of Patients Who Experienced 50% or Greater Wound Healing

    Time frame: 3 Weeks

    Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported

Secondary outcomes

  1. Number of Patients Reporting Pain

    Time frame: 3 Weeks

    Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.

  2. Erythema at Week 3

    Time frame: 3 Weeks

    At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with "0" being "No erythema", "1" being "Very slight erythema", "2" being "Well defined erythema", "3" being "Moderate to severe erythema" and 4 being "Severe erythema to slight eschar formation"

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 a Curettage and Electrodesiccation of Skin Lesions

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2008
Registry last updated
Mar 9, 2011

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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