A Phase I/II Randomized Trial to Determine the Safety of a Novel Donor Site Dressing (Product X)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).
研究概览
简要总结
The goal of this clinical trial is to test a novel donor site dressing called Product X in burn patients requiring skin grafting procedures. A donor site is an area where the surgeon has taken a layer of skin to create a graft. This is required to make severe burn wounds heal. However, donor sites often experience infection, pain, and itch that can delay the healing of the donor site. To prevent these complications, donor sites are covered with dressings to prevent infection and absorb fluids from the wounds. Many options exist, but no single dressing is best, especially for pain management and the ability to absorb fluids from wounds effectively.
The investigators have developed a new donor site dressing to meet the criteria of an "ideal dressing," called Product X. The main question this clinical trial aims to determine the safety and potential wound-healing benefits of this donor site dressing as a new therapy that will help patients who require donor sites.
Participants will:
- Be randomized, like a flip of a coin, to receive either Product X or the standard-of-care dressings. If patients have one donor site, it will be randomized to receive either Product X or the standard-of-care dressings, Allevyn and Xeroform. If they have two donor sites, one donor site will be randomized to receive Product X and the other to receive standard-of-care dressings.
- Have photographs of their donor sites taken at the operation, during dressing changes, at discharge, and at regularly scheduled outpatient follow-up appointments with the burn clinic.
- Complete short questionnaires to assess their comfort (pain and itch) with their donor sites daily.
- Complete a scar formation questionnaire at your regularly scheduled follow-up appointments in the outpatient burn clinic.
Researchers will compare Product X to standard-of-care dressings (Allevyn and Xeroform) to see if there are improvements in wound healing, pain, itch, and infection.
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
- •≥18 years of age;
- •<25% total body surface area (TBSA) burn;
- •Deep partial or full-thickness burn requiring operative procedures;
- •Autologous donor site(s) on thigh, torso, and/or arm.
排除标准
- •Patients who are moribund.
- •Active cancer and currently undergoing treatment.
研究组 & 干预措施
Standard-of-Care
干预措施: Standard-of-Care (Device)
Product X
干预措施: Product X (Device)
结局指标
主要结局
Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).
时间窗: At 3 months and 6 months post-hospital discharge.
Scores will range from 1 to 10 for each measure, with higher scores indicating worse scarring.
Number of non-healing donor sites
时间窗: From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.
Non-healing donor site requiring additional (unplanned) OR.
Number of donor site infections
时间窗: From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.
Donor site infection requiring antibiotic/antifungal treatment or additional (unplanned) OR.
次要结局
- The amount of excess bleeding from the donor site measured by the need for interventions to control the bleeding.(From date of donor site dressing application until last dressing takedown, assessed up to 52 weeks.)
- Range of motion of the donor site measured by the ability to actively participate in therapy sessions.(From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.)
- Itch(From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.)
- Time from autografting procedure to 95% healing of donor site.(From date of donor site dressing application until hospital discharge, assessed up to 52 weeks.)
- Scar formation over time using the Patient and Observer Scar Assessment Scale(At 3 months and 6 months post-hospital discharge.)
- Absorption of wound exudate measured daily by the amount of dressing required and the number of additional dressing changes needed.(From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.)
- Donor Site Pain(From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.)
- Number of patients experiencing adhesion of the dressing to the donor site(From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.)