An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Part A: Number of Participants With Healing
研究概览
简要总结
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.
Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
详细描述
This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation.
A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects.
Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%.
The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent.
The subjects were participating in the study for 14 days postop.
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
- None
入排标准
- 年龄范围
- 18 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Subjects with burn injury resulting in up to 30% TBSA
- •Full thickness area of burn should not be more than 20%
- •Area in need of skin grafting can be 1-15% TBSA
- •Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product
- •Thermal injuries only
- •Subjects age 18 months to < 65 years.
- •Signed informed consent
- •Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
排除标准
- •Greater than 30% TBSA
- •Full thickness areas greater than 20% TBSA
- •Full thickness area to be grafted less than 1%
- •Presence of respiratory involvement
- •Subjects on mechanical ventilation
- •Subjects with infected burn wounds
- •Subjects with organ failure
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment
- •Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent
- •Known allergy/hypersensitivity to any of the components of the investigation products.
- •Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed
- •Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- •Previous randomized to this investigation
- •Inclusion Criteria
- •There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)
- •Exclusion Criteria
- •Investigator do not agree to treat the donor site with Mepilex Transfer Ag
- •The subject do not agree to participate in the donor site part
研究组 & 干预措施
Mepitel® Ag
A dressing device used for surgical burn wounds with skin graft.
干预措施: Mepitel® Ag (Device)
Mepilex® Transfer Ag
Donor site dressing device in the very same patient.
干预措施: Mepilex® Transfer Ag (Device)
结局指标
主要结局
Part A: Number of Participants With Healing
时间窗: 14 days
Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Part B
时间窗: 14 days with 2 visits
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
次要结局
- Part A Secondary Outcome.(14 days with 2 visits)
- Part B Secondary Outcome.(14 days with 2 visits)