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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

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Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Shapes by PolyMem dressing

Intervention Type DEVICE

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.

Group Type OTHER

Shapes by PolyMem Silver Dressing

Intervention Type DEVICE

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.

Group Type OTHER

Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site

Intervention Type DEVICE

Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.

Interventions

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Shapes by PolyMem dressing

Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site

Intervention Type 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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes