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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Ferris Mfg. Corp..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Chicago Skin Clinic
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Ferris Mfg. Corp.
ClinicalTrials.gov Identifier:
NCT00727870
First received: July 31, 2008
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Healing
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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..

Resource links provided by NLM:


Further study details as provided by Ferris Mfg. Corp.:

Primary Outcome Measures:
  • Preference by both clinician and consumer of dressing choice in managing shave biopsy sites. [ Time Frame: At completion of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: At completion of protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2008
Estimated Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727870

Locations
United States, Illinois
Chicago Skin Clinic
Chicago, Illinois, United States, 60641
Sponsors and Collaborators
Ferris Mfg. Corp.
Chicago Skin Clinic
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Andrew M Gorchynsky, MD Chicago Skin Clinic
Principal Investigator: Danilo V Del Campo, MD Chicago Skin Clinic
  More Information

No publications provided

Responsible Party: Ferris Mfg. Corp.
ClinicalTrials.gov Identifier: NCT00727870     History of Changes
Other Study ID Numbers: PolyMem001
Study First Received: July 31, 2008
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ferris Mfg. Corp.:
Shave Biopsy management
"Biopsy/adverse effects"[Mesh]
"Biopsy/complications"[Mesh])

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 17, 2014