Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Wound closure
研究概览
简要总结
This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.
详细描述
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Only the individual performing dressing changes will know which dressing is applied to which site. All others will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thermal injury size 5-30% TBSA
- •Admitted to the burn center and enroll able within 72 hours of injury
- •Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth.
- •The subject and or caregiver is able and willing to follow the protocol requirements
- •Achieve wound photos and dressing change at 3 days
排除标准
- •Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
- •Subject is undergoing hospice care.
- •Subject is currently being treated for an active malignant disease
- •Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
- •Known contraindications to silver metals, silver chloride, or silver tetraoxide
- •Known contraindications to lidocaine
- •Known allergies to any components of either primary dressing in the study
- •Known allergies to the silicone or adhesives in secondary dressings
- •Burns located on the hands, feet, face, and/or genitals will be excluded from treatment sites, but will be included in the total TBSA calculation
- •Subject has a combined TBSA of 31% or greater of partial and/or full thickness burn wounds
- •Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- •Subject is pregnant, breast feeding, or planning to become pregnant.
- •Subjects who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, application of topical steroids within one month prior to enrollment, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- •Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application.
- •Burn study site(s) has been previously treated with a silvadene
研究组 & 干预措施
FSWD wound site
One burn wound site on each participant will receive study treatment.
干预措施: Field Shield Wound Dressing (Device)
Control treatment
One burn wound site on each patient receives standard treatment with silver dressing.
干预措施: Silverlon (Device)
结局指标
主要结局
Wound closure
时间窗: From enrollment to end of study, 4-6 months.
Wound closure will be assessed at each time point (day 3, 7, 12, 19, 28, 35). The probability of wound closure will be assessed with a cluster randomized Generalized Estimating Equations (GEE) model of the probability of closure in terms of treatment and clinical site with clustering by patient and login link.
次要结局
- Infection(35 days)
- Pain severity(days 3, 7, 12, 19, and 28.)
- Surgical debridement(35 days)
- Health-related quality of life(day 35 and 4-6 months)
- Scar(day 35 and 4-6 months)
- Function(Day 3, 35 and 4-6 months)