NCT00727870Unknown4 期
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..
Ferris Mfg. Corp.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study.
排除标准
- •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
结局指标
主要结局
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
时间窗: At completion of protocol
次要结局
- 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)
研究者
研究点 (2)
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