Evaluation of Preferences of Consumers and Clinicians for the Management of Shave Biopsy Sites With a PolyMem Formulation Dressing or Current Standard of Care.

Phase 4

• Conditions: Healing
• Interventions: Device: Shapes by PolyMem dressing; Device: Shapes by PolyMem Silver Dressing; Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site

• Registration Number: NCT00727870
• Lead Sponsor: Ferris Mfg. Corp.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Shapes by PolyMem dressing	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 dressing.
2	Shapes by PolyMem Silver Dressing	Arm 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	Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site	Arm 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.

Primary Outcome Measures

Name	Time	Method
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.	At completion of protocol

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chicago Skin Clinic; 🇺🇸 Chicago, Illinois, United States