NCT00816101

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 1, 2011

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2011

Enrollment Period

6 months

First QC Date

October 21, 2008

Results QC Date

December 13, 2010

Last Update Submit

March 4, 2011

Conditions

Acute Wounds

Keywords

Curettage and electrodesiccationacute woundspartial thickness wounds

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Experienced 50% or Greater Wound Healing

    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

    3 Weeks

Secondary Outcomes (2)

  • Number of Patients Reporting Pain

    3 Weeks

  • Erythema at Week 3

    3 Weeks

Study Arms (3)

PROCELLERA™Antimicrobial Dressing

EXPERIMENTAL

Dressing changes every 3 days, more frequently if needed

Other: Procellera™ Antimicrobial Dressing

Mepilex® Border Lite

ACTIVE COMPARATOR

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

Other: Mepilex® Border Lite

Band-Aid® Adhesive Bandage

ACTIVE COMPARATOR

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

Device: Adhesive Bandage

Interventions

Procellera™ Antimicrobial DressingOTHER

Dressing indicated for partial and full-thickness wounds.

Also known as: PROCELLERA™, Prosit™ Antimicrobial Dressing, Prosit™ Technology
PROCELLERA™Antimicrobial Dressing
Mepilex® Border LiteOTHER

Self-adherent foam dressing

Also known as: Mepilex®
Mepilex® Border Lite
Adhesive BandageDEVICE

Adhesive bandage

Also known as: Band-Aid® Adhesive Bandage
Band-Aid® Adhesive Bandage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheftel Associates Dermatology

Tucson, Arizona, 85718, United States

Location

Results Point of Contact

Title
Scott Sheftel, MD
Organization
Sheftel Associates Dermatology, LLC
ssheftel@sheftelderm.com
520-293-5757

Study Officials

  • Scott N Sheftel, MD

    Sheftel Associates Dermatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 21, 2008

First Posted

December 31, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

March 9, 2011

Results First Posted

March 1, 2011

Record last verified: 2011-03

Locations

US(1)