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

Ferris Mfg

Status and phase: Unknown; Phase 4

Conditions: Healing

Treatments: Device: Shapes by PolyMem Silver Dressing; Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site; Device: Shapes by PolyMem dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00727870

PolyMem001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

1

Other group

Description:

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.

Treatment:

Device: Shapes by PolyMem dressing

2

Other group

Description:

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.

Treatment:

Device: Shapes by PolyMem Silver Dressing

3

Other group

Description:

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.

Treatment:

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