An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 12
- 主要终点
- Wound progression
研究概览
简要总结
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit.
Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.
详细描述
This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag+ and Exufiber in managing burn healing.
The primary objective of this study is to evaluate the clinical safety and performance of all study dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. The dressings are intended to promote healing through the management of the wound environment.
Sixty-eight (68) subjects with partial thickness burns will be treated with either Exufiber Ag+ (34 subjects) or Exufiber (34 subjects) primary dressings, at the discretion of the Investigator. Secondary dressings should be non-adherent, non-antimicrobial dressings (local treatment praxis).
Each Subject will be evaluated at five (5) planned study visits for a maximum total treatment period of up to 21 days, unless the burn heals.
Visit 1 is a baseline visit to enroll Subjects and determine burn extent. Each Subject will be assigned to either Exufiber Ag+ or Exufiber primary dressings and treated according to the Instructions for Use (IFU) and the local clinical routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Wound size and tissue type will be assessed by a single, blinded, third-party clinician. The clinician will use imaging software to measure the size of the wound and identify tissue types, from baseline to last clinical follow-up.
入排标准
- 年龄范围
- 4 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Burn of thermal origin
- •Patients presenting with partial thickness burns covering < 5% TBSA for study treatment
- •TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
- •Clean wounds with ≤10% necrotic tissue
- •Patients presenting with moderate to high exuding wounds
- •Serous or Serosanguinous exudate
- •Patient is not contraindicated for the dressing to which he/she is assigned
排除标准
- •Electrical Burns
- •Chemical Burns including acidic or basic sources
- •Ionizing radiation injuries
- •Patients with delayed presentation for burn care (>72 hours from time of injury)
- •Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
- •Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment
- •Clinically infected burn
- •Patients with insulin dependent diabetes mellitus
- •Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent
- •Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days
- •Known allergy/hypersensitivity to any of the components of the investigation products
- •History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)
- •Patients that are not expected to comply with the investigation due to physical and/or mental conditions
- •Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- •Previously enrolled in this investigation
结局指标
主要结局
Wound progression
时间窗: 5 weeks
A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved
次要结局
- Wound Exudate(5 weeks)
- Dressing conformability(5 weeks)
- Re-epithelialization of wound(5 weeks)
- Wound Redness/Irritation peri-wound skin(5 weeks)
- Subject pain(5 weeks)
- Dressing ability to absorb blood(5 weeks)
- Wound Size(5 weeks)
- Time to discontinuation of study dressings(5 weeks)
- Wound Maceration(5 weeks)
- Exudate Nature(5 weeks)
- Burn odor(5 weeks)
- Rewetting(5 weeks)
- Dressing ability to rehydrate(5 weeks)
- Local infection(5 weeks)
- Dressing Adherence(5 weeks)
- Dressing ability to retain balanced moist environment(5 weeks)
- Blistering(5 weeks)
- Dressing ability to retain exudate(5 weeks)
- Dressing ability to clean wound bed(5 weeks)
- Dressing ability to retain gelling properties(5 weeks)
- Dressing flexibility(5 weeks)
- Proportion of Burn Healed(5 weeks)
- Malodor(5 weeks)
- Dressing ability to retain slough(5 weeks)
- Ease of dressing application(5 weeks)
- Dressing removal in one piece(5 weeks)
- Residuals of dressing material in the wound or surrounding skin(5 weeks)
- Bleeding at removal(5 weeks)
- Ease of dressing removal with and without moistening(5 weeks)