Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of healing wound progress across study window
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.
详细描述
Current management options for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.
This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).
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
- •Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion.
- •Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment.
排除标准
- •Inability to provide informed consent
- •Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns
- •Radiation, chemical or electrical burn injury
- •Patients with burns primarily located to the face, genitals, or span across joints
- •Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic.
- •Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe
- •Patients with documented or self-reported shellfish allergies
- •Current pregnancy
- •Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion
- •Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.
研究组 & 干预措施
SynePure with Catasyn
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
干预措施: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (Device)
Silvadene
Routine care wound rinse and Silvadene cream
干预措施: SILVADENE Cream 1% (silver sulfadiazine) (Drug)
结局指标
主要结局
Percentage of healing wound progress across study window
时间窗: Up to 21days
Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area
次要结局
- Number of new infection rates(Up to 21days)