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

Healing Clinical Trial

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..

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00727870
• Other study ID #: PolyMem001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 31, 2008
• Last updated: March 1, 2012
• Start date: July 2008
• Est. completion date: June 2012

Study information

• Verified date: March 2012
• Source: Ferris Mfg. Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healing

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
United States	Chicago Skin Clinic	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Ferris Mfg. Corp.	Chicago Skin Clinic, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.		At completion of protocol	No
Secondary	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	No