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..

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.

Study Overview

• Status: Unknown
• Conditions: Healing
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60641
      • Chicago Skin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 1; 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.	Device: Shapes by PolyMem dressing; Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
OTHER: 2; 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.	Device: Shapes by PolyMem Silver Dressing; Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
OTHER: 3; 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.	Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site; Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.	At completion of protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ferris Mfg. Corp.
• Collaborators: University of Minnesota; Chicago Skin Clinic
• Investigators: Principal Investigator: Andrew M Gorchynsky, MD, Chicago Skin Clinic; Principal Investigator: Danilo V Del Campo, MD, Chicago Skin Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ANTICIPATED): June 1, 2012

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (ESTIMATE): August 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 2, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Shave Biopsy management; "Biopsy/adverse effects"[Mesh]; "Biopsy/complications"[Mesh])
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: PolyMem001