FORCEREPAIR - A Wound Exudate Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts
研究概览
简要总结
The observational longitudinal study will collect wound exudate from twenty patients with venous leg ulcers. Wound exudate samples are collected using twenty-four-hour collection with polyurethane foam, bandages and the NovaSwab method. Each patient is seen four times where wound exudate and the bacteria microbiome are sampled and wound size is monitored with advanced planimetric tools.
详细描述
This dual centre longitudinal observational study will run from January 2024 to January 2025. The investigation will include twenty patients over four weeks including four study visits. Sampling of wound exudate can take place on every visit and will be made with the polyurethane discs, the NovaSwab technique and waste bandages. The wound bacteria microbiome is sampled with routine bacterial swabs. Tape strips will be used to assess perilesional skin and control sites of normal skin and will primarily measure skin inflammation parameters. Clinical pictures are taken and analysed using advanced planimetric tools. Patients enrolled receive standard wound care; allowing all kinds of dressing. However when consenting to twenty-four-hour-collection patients will not be allowed to wear active bandages or receive antibiotic treatment for that period. Compression, wound dressings, and use of topical and oral antibiotics will be registered. For the storage of samples, a research biobank is used, and leftover material will be stored in a biobank for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adults fulfilling all inclusion criteria
- •Age >18 years
- •Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification)
- •Wound Area equal to or above 1 cm2 (measured with a ruler length x width)
- •Patient can understand Danish
- •Patient can comply with protocol
- •Patient is fully informed about the study and has given informed consent
排除标准
- •Venous leg ulcer with communication to bone
- •Known or suspected cancer in the wound
- •Allergies towards products used in the study, e.g. polyurethane foam and tegaderm
- •Judgement by the investigator that the patient is not suited for study participation
结局指标
主要结局
Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts
时间窗: Four weeks
Matrix Formation
Wound Exudate Effects on Release of Pro-inflammatory Mediators
时间窗: Four weeks
Release of pro-inflammatory Mediators
Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts
时间窗: Four weeks
Gene Expression Profiles
Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts
时间窗: Four weeks
Proliferation
Exploratory Wound Exudate Compound and Device Testing
时间窗: Four weeks
Wound Exudate Compounds
次要结局
- Wound Microbiome 16 rRNA/18sRNA(Four Weeks)
- Percentage Area Reduction Relation to Wound Microbiome Profile(Four Weeks)
- Wound Perilesional Skin Inflammation(Four Weeks)
- Wound Exudate Profile Relation to Percentage Area Reduction(Four Weeks)
- Comparisson of Wound Exudate Sampling Techniques(Four Weeks)
- Wound Exudate Profile Relation to Wound Microbiome Profile(Four Weeks)
研究者
Frederik Plum
MD, Ph.D Fellow at University of Copenhagen
Bispebjerg Hospital