NCT01654094已完成不适用
A Multicenter, Prospective, Randomized Study to Compare Milliken Dressing P6 to Mafenide Acetate 5% Solution as a Split Thickness Skin Graft Cover Dressing in Burn Wound Patients.
Milliken Healthcare Products, LLC4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Management of skin grafts as determined by investigator's visual assessment of percent graft take
研究概览
简要总结
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have thermal burns from scalds, flame/fire or contact with a hot object.
- •Patients must have a TBSA burn of less than or equal to 50%.
- •Patients must have two nonadjacent study burn sites (i.e., separated in such a way that SOC dressing does not contaminate the study dressing) of comparable size (up to approximately 2% TBSA) and severity requiring excision and grafting.
- •Patients must have undergone excision and autografting on or before post-burn day (PBD)
- •Patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion.
- •Patients expected to be available for assessment of study burn sites at least until POD 6 ±1 day.
- •Males or females at least 18 years of age but no older than 65 years of age at the time of informed consent.
- •Patient and / or Legally Authorized Representative (LAR) voluntarily agrees to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
排除标准
- •Patients with electrical or chemical burns.
- •Patients with a study burn site excised and "grafted" with Integra.
- •Patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears.
- •Patients taking vasopressors or inotropes.
- •Patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.).
- •Patients with acute renal failure, defined as creatinine clearance (CrCL) >2.5 mg/dL or AKIN score greater than or equal to 2 or estimated GFR < 30, if the assessment is conducted as part of the patient's routine clinical care.
- •Patients with acute respiratory distress syndrome (ARDS), if the assessment is conducted as part of the patient's routine clinical care.
- •Patients with liver cirrhosis (Childs-Pugh B Class or greater) or who have AST / ALT levels greater than or equal to 2 times the upper limit of theinstitution's normal range, if the assessment is conducted as part of the patient's routine clinical care.
- •Patients with a known sensitivity or known intolerance to mafenide acetate (Sulfamylon) or to silver.
- •Patients with any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study.
- •Patients who are breastfeeding, pregnant or expecting to become pregnant during the study..
- •Patients who have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation.
研究组 & 干预措施
P6 Low Adherent Dressing
Experimental
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
干预措施: P6 Low Adherent Dressing (Device)
Standard of Care (SOC)
Active Comparator
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Management of skin grafts as determined by investigator's visual assessment of percent graft take
时间窗: 6 days
次要结局
- Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.(15 days)
- The incidence of post-operative graft infections(15 days)
- Assessment of patient's pain / discomfort, using a visual analog scale.(15 days)
- Costs of study burn site wound dressing regimens.(15 days)
- Ease of use and clinician preference of the study burn site wound dressing regimens(15 days)
- Statistical robustness of visual graft take assessments in-person and from digital photographs(15 days)
- Progression of percent graft take with time for both P6 and SOC.(15 days)
研究者
研究点 (4)
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