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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00727870

Enrollment

Registered

2008-08-04

Start date

2008-07-31

Completion date

2012-06-30

Last updated

2012-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing

Keywords

Shave Biopsy management, Biopsy/adverse effects[Mesh], Biopsy/complications[Mesh])

Brief 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.

Interventions

DEVICEShapes by PolyMem dressing

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

DEVICEShapes 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

DEVICEShapes 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026