NCT00727870

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..

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ferris Mfg. Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healing

Interventions

Type	Name	Description
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
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
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-10-01
• Completion: 2012-06-01
• First posted: 2008-08-04
• Last updated: 2012-03-02

Locations

1 site across 1 country: United States