Overview

This trial is active, not recruiting.

Condition healing
Treatments shapes by polymem dressing, shapes by polymem silver dressing, shapes by polymem on one site and shapes by polymem silver dressing on second site
Phase phase 4
Sponsor Ferris Mfg. Corp.
Collaborator Chicago Skin Clinic
Start date July 2008
End date October 2011
Trial size 90 participants
Trial identifier NCT00727870, PolyMem001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
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)
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.
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)
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.
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.

Primary Outcomes

Measure
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
time frame: At completion of protocol

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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..
Principal investigator Andrew M Gorchynsky, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Ferris Mfg. Corp..