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 Overview
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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.

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.

Official Title
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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..

Conditions
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Healing

Intervention / Treatment
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* 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


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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<br>* Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site<br>|
| Other: 2<br>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<br>* Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site<br>|
| Other: 3<br>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<br>* Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference by both clinician and consumer of dressing choice in managing shave biopsy sites. |  | At completion of protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shave Biopsy management, Biopsy/adverse effects[Mesh], Biopsy/complications[Mesh])