NCT00727870UnknownPhase 4
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..
Ferris Mfg. Corp.2 sites in 1 country90 target enrollmentStarted: July 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
Study Overview
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.
Detailed Description
Only individuals who require 2 shave biopsies on the same treatment day will be entered in the study. Each participant serves as their own control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study.
Exclusion Criteria
- •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 use aspirin or non-steroidal anti-inflammatory drugs more than 3 times per week for pain (daily low dose aspirin use for cardiovascular health is not an exclusion criteria)
- •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
Outcomes
Primary Outcomes
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
Time Frame: At completion of protocol
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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