跳至主要内容
临床试验/NCT02318056
NCT02318056撤回不适用

The Burn Glove Trial-A Randomized Controlled Trial of Dressings for Partial Thickness Hand Burns

Southern Illinois University1 个研究点 分布在 1 个国家开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
pain

研究概览

简要总结

Specific Aim 1: To determine if one of three burn dressings provides a less painful healing experience for partial thickness hand.

Specific Aim 2: To evaluate if one of three dressings provides greater functionality during and after healing of partial thickness hand burns.

Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.

详细描述

Various products are on the market and available for use on partial thickness burns to the hand/s. Our current institutional standard of care is to use Xeroform Gauze (Coviden, Mansfield, MA) and Bacitracin Ointment (Fougera, Melville, NY) to promote a moist antibacterial healing environment with the ability to monitor the healing progress daily. However, silver (AG) based dressings that employ nanocrystalline technology with hydrofiber (Aquacel AG burn; ConvaTec, Princeton, NJ) or soft silicone foam (Mepilex AG ; Molnlycke Health Care, Dunstable, United Kingdom) have been well accepted as alternative dressing solutions. These dressings have longer interval times between changes, leading to a reported increase in patient comfort, diminished skin shearing/stripping, and rapid re-epithelialization.

Given the anatomic intricacies, partial thickness burns to the hand present a challenge in dressing selection. Recently, ConvaTec unveiled the Aquacel AG Burn Glove for use on partial thickness hand burns. In line with this idea, our institution has now begun to fashion a novel burn glove out of Mepilex Transfer AG with good success. To date there are no known studies that compare Xeroform/Bacitracin, Aquacel AG burn glove or Mepilex Transfer AG dressing. The goal of this study is to compare these three burn dressings used to treat partial-thickness hand burns and their impact on pain, function, and aesthetic outcomes. We will also explore psychosocial issues related to hand burn dressing changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting at Memorial Medical or Southern Illinois University (SIU) Health Care
  • Patients with partial-thickness burn injuries to the dorsum and/or palm of the hand/s that exceeds ½% total body surface area (TBSA) for at least one hand.
  • < 10% TBSA 2nd and 3rd degree burn injuries
  • Initial clinical presentation < 5 days post burn injury

排除标准

  • < ½ % TBSA involving the hand
  • > 10%TBSA burn injuries
  • > 60 years of age
  • < 8 years of age
  • Patients (or parents of minors) without cognitive capacity to comprehend informed consent
  • Presentation > 5 days post-burn injury event
  • Pregnant women
  • Full thickness/3rd degree burns to the dorsal and/or palmer hand/s
  • Exposed vital structures (tendons, nerves, bone, vessels)
  • Uncontrolled Type II Diabetes
  • Type I Diabetes
  • History of Chronic Obstructive Pulmonary Disease
  • Have a known allergy to silver products
  • Signs of infection on initial clinical presentation (presence of purulent drainage, significant cellulitis, and/or fever)
  • Smoke/inhalation injuries requiring ventilation
  • Critically ill patients requiring intensive care

研究组 & 干预措施

Aquacel® Ag Burn Glove

Experimental

Application of Aquacel® Ag Burn Glove burn dressing

干预措施: Aquacel® Ag Burn Glove (Other)

Mepilex® Transfer Ag

Active Comparator

Application of Mepilex® Transfer Ag burn dressing

干预措施: Mepilex® Transfer Ag (Other)

Xeroform®/Bacitracin®

Active Comparator

Application of Xeroform® burn dressing and Bacitracin® topical antibiotic

干预措施: antibiotic (Drug)

结局指标

主要结局

pain

时间窗: baseline to 6 months post-burn injury

pain as measured by the Patient and Provider Scar Assessment Scale

次要结局

  • functionality(baseline to 6 months post-burn injury)
  • aesthetic appearance(baseline to 6 months post-burn injury)
  • pain(baseline to 6 months post-burn injury)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验