Evaluation of Preferences of Consumers and Clinicians for the Management of Shave Biopsy Sites With a PolyMem Formulation Dressing or Current Standard of Care.
A Single Site, Three Arm, Open Label Comparative Preference Study to Evaluate the Preference of Consumers and Health Care Professionals for the Use of Shapes by PolyMem Wound Dressings and Shapes by PolyMem Silver Wound Dressings, Each Compared to Antibiotic Ointment Covered With a Band-aid Type Dressing (Current Standard of Practice) and to Each Other in the Post-biopsy Management of Shave Biopsies. Each Participant Serves as Own Control. A Blinded Third Party Physician Will Evaluate and Compare the Wounds Based on Photos Taken at the Various Follow-up Points..
1 other identifier
interventional
90
1 country
1
Brief Summary
Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 2, 2012
March 1, 2012
3.3 years
July 31, 2008
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
At completion of protocol
Secondary Outcomes (1)
Evaluations and comparisons by both treating physician and blinded physician of each site for differences in inflammation, signs of possible infection, reepithelialization and cosmetic appearance
At completion of protocol
Study Arms (3)
1
OTHERAfter the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem dressing.
2
OTHERArm 2: after the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem Silver dressing.
3
OTHERArm 3: after the two biopsies, one site will be covered with Shapes by PolyMem dressing and the other site will be covered the Shapes by PolyMem Silver dressing.
Interventions
Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.
Eligibility Criteria
You may not qualify if:
- Those that have used systemic corticosteroids in the last three months.
- Those with any medical condition leading to immunosuppression
- Those with a history of keloid formation
- Those with documented compromised wound healing potential
- History of psoriasis or eczema in the last 2 years
- Those with an active infection
- Those that have inflammatory conditions such as rheumatoid arthritis or Crohn's disease
- Those that have clinical signs of malnutrition that could interfere with wound healing
- Those that have a history of allergies to any wound dressing or medical tape
- Those that are not able to change the dressing themselves and do not have anyone in their household that can change the dressings if needed.
- Those younger than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferris Mfg. Corp.lead
- Chicago Skin Cliniccollaborator
- University of Minnesotacollaborator
Study Sites (1)
Chicago Skin Clinic
Chicago, Illinois, 60641, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew M Gorchynsky, MD
Chicago Skin Clinic
- PRINCIPAL INVESTIGATOR
Danilo V Del Campo, MD
Chicago Skin Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 4, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2011
Study Completion
June 1, 2012
Last Updated
March 2, 2012
Record last verified: 2012-03