An Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in wound progress
研究概览
简要总结
This is a single-centre prospective, open, non-comparative, Post-Market Clinical Follow-up (PMCF) investigation to confirm performance and safety of Exufiber® (Gelling fibre dressing) when used as intended on donor sites through assessment of wound progression from baseline to the subject´s last visit.
详细描述
A single-centre prospective, open, non-comparative, PMCF investigation to confirm performance and safety of Exufiber® (gelling fibre dressing) when used as intended on donor sites. The investigation will include eligible subjects undergoing split skin graft transplantation for harvesting of a partial-thickness skin graft, i.e. excision of the epidermis and part of the dermis. After the study inclusion (baseline) the patient will go through the split skin graft transplantation following application of the Exufiber® dressing, Mepilex®(non-border) dressing, and any third dressing as required on the donor site. Each subject will thereafter be followed up on days 3, 14, and 21 prior completion in the study.
A subject may complete the study prior to or on day 14 as well as in between day 14 and day 21 if the donor site is healed. Wound healing progression will be determined by the investigator/designee and assessed as:
- 100% re-epithelialisation including small residual scabs/blisters and open areas less than 1 cm within an otherwise fully re-epithelialised area, and/or
- less than 100% re-epithelialization but to the extent that the Exufiber dressing is not required anymore
If the donor site is not healed and the donor site is dry and therefor not treatable with Exufiber the patient will be treated according to clinical praxis and followed for outcomes on the following visits.
Approximately 34 eligible subjects will be included in one centre in Sweden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female or male ≥18 years old.
- •Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
- •Planned hospitalization for at least 3 days post-transplantation.
- •Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
- •Provision of written informed consent
排除标准
- •Burn injury of ≥20% of total body surface area.
- •Diagnosed with paraplegia.
- •Harvested graft from the same donor site location before.
- •Donor sites not to be harvested with dermatome
- •Pregnancy or lactation at the time of screening.
- •Known allergy/hypersensitivity to Exufiber, Mepilex or other components/products used in this investigation.
- •Participating in other ongoing clinical investigation that may impact the outcome of this investigation based on the judgement of the investigator.
- •Not able to read or understand Swedish.
- •Any other conditions that according to the investigator may make follow-up or investigation inappropriate.
结局指标
主要结局
Change in wound progress
时间窗: Day 14(-1 day), Day 21(+-1 day)
Wound progress compared between each visit up to final visit and assessed as: * Deteriorated * No change * Improved
次要结局
- Change in wound progress(Day 14(-1 day))
- Wound healing progress(Day 14(-1 day), Day 21(+-1 day))
- Ability of dressing to absorb blood(Day 21(+-1 day))
- Exudate leakage(Day 21(+- 1 day))
- Ease of handling(Day 21(+-1 day))
- Comfort and experience(Day 21(+-1 day))
- Change in exudate amount and type(Day 14(-1 day), Day 21(+- 1 day))
- Ability of dressing to stay in place(Day 21(+- 1 day))
- Ease of dressing removal(Day 21(+- 1 day))
- Dressing conformability(Day 21(+- 1 day))
- Dressing integrity(Day 21(+- 1 day))
- Follow-up assessment of wound healing when treated according to clinical praxis(Day 21(+-1 day))
- Wound size(Day 14(-1 day))
- Local infection(Day 14(-1 day), Day 21(+- 1 day))
- Subject's pain(Day 14(-1 day), Day 21(+- 1 day))
- Subject's itching(Day 14(-1 day), Day 21(+- 1 day))
- Ability of dressing to retain exudate(Day 21(+- 1 day))
- Ability of the dressing to retain blood(Day 21(+- 1 day))
- Blood leakage(Day 21(+- 1 day))
- Ability of dressing to absorb exudate(Day 21(+-1 day))
- Subject's quality of life assessment(Day 21(+- 1 day))
- Dressing wear time(Day 3, Day 14(-1 day), Day 21(+- 1 day))
- pH level measurement(Day 3)