NCT05499104已完成3 期
A Prospective, Randomized, Controlled Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Joseph M. Still Research Foundation, Inc.2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2021年7月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Pain and Healing
研究概览
简要总结
This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
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
- •Is ≥18 years of age.
- •Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
- •Subject is able to provide informed consent.
- •Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.
排除标准
- •Has a Baux Score of ≥
- •Subject is intubated, unable to state pain levels.
- •Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
- •Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
- •Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
- •Is pregnant, plans to become pregnant, or is actively breastfeeding.
- •Active illicit drug use.
- •Is moribund, or in the opinion of the investigator is not expected to survive.
结局指标
主要结局
Pain and Healing
时间窗: 14 days
To compare and healing (defined as \>95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing.
次要结局
- Management of bloody exudate(14 days)
- Conformability(14 days)
- Absorbent ability(14 days)
- Adherence(14 days)
- Ease of removal(14 days)
- Cost(14 days)
研究者
研究点 (2)
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