Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-thickness Burns
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Days to Healing of the Superficial Partial Thickness Burn Wound.
研究概览
简要总结
This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)
详细描述
Current effective dressings 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.
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
- 否
入选标准
- •Ability to provide informed consent
- •18 years of age or older, male and female
- •Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA)
- •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 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 ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic.
- •Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrine disease, hepatic disease, or renal disease; or other severe conditions for whom, in the physician 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
Silver sulfadiazine
Topical management via dressings provide a barrier against microbial infection. The current gold standard for burn wound dressings is silver (nanoparticulate or ionic), and it has shown some efficacy in treating infections, but it does not demonstrate an ability to prevent infections and some treatment guidelines even recommend against its use. Although silver dressing is preferred for military use, a retrospective review spanning 10 years of use in military environments showed that silver was not more effective than other antimicrobial topical treatments, and a meta-analysis with over 2500 surgical patients found silver sulfadiazine was associated with increased infection rates and hospital length-of-stays were two days longer on average.
干预措施: Silver Sulfadiazine (Drug)
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Synedgen has developed Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. These products are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure™ Wound Cleanser is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn™ Advanced Technology Hydrogel serves as a protective gel dressing. Together, these products reduce inflammation in wounds, aggregate bacteria and disrupt bacterial biofilms, and accelerate healing.
干预措施: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser (Device)
结局指标
主要结局
Number of Days to Healing of the Superficial Partial Thickness Burn Wound.
时间窗: up to 21 days
Number of days to healed burn wound (re-epithelialization as defined by greater than or equal to 90% epithelialized wound, determined by investigator exam and review of wound photographs, as needed)
Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score
时间窗: up to 21 days
The patient and observer scar assessment scale (POSAS) is used to measure scar quality. It is composed of a patient reported section and an observer reported section (6 scored items each). Each section consists of items on a ten-step scale (1= as normal skin to 10=very different from normal skin/worst scar imaginable). A higher score indicates more symptoms/issues present; the lower the score the closer to normal skin. These sections are then summed together to make up the total score (maximum of 120 and minimum of 12). Please note the means listed denote the difference in POSAS score between the baseline and last assessment completed (21 days if last visit completed, or earlier visit if withdrawn or lost to follow up).
次要结局
- Safety- Rate of Complications From Screening Visit to Visit 8(up to 21 days)
- Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8(up to 21 days)
- Safety- Infection Rate From Screening Visit to Visit 8(up to 21 days)
- Safety- as Measured by Change in Total Vancouver Scar Scale Score From Screening Visit to Visit 8, or to Last Visit Completed, for the Three Lost to Follow up Participants, and 1 Participant Who Was Withdrawn.(up to 21 days)
研究者
J. Peter Rubin, MD
Endowed Chair of Plastic Surgery
University of Pittsburgh