Hair Cycle Modulation To Promote Human Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Photograph Assessment
研究概览
简要总结
Chronic wounds represent a huge burden to both patients and the National Health Service (NHS), with over 200,000 sufferers in the UK alone. Based on current conservative estimates the NHS spends £2.3 - £3.1 billion pounds every year treating these patients.
This study aims to reduce this shared burden, preliminary data from our research group using animal models has demonstrated variable ability of hair follicles to heal wounds based upon their stage within their growth cycle. This currently proposed study therefore aims to perform a simple novel intervention on patients prior to their elective surgery in an effort to replicate the substantial healing abilities noted in the animal models.
Under normal circumstances, a patient's operative site is shaved prior to the surgery for hygiene and visual simplicity. The aim of this study is to wax 50% of the patient's operative site prior to their surgery, the other half will be shaved on the day of surgery as per normal surgical protocol. Based on known data this waxing technique will cycle the hair follicles into their growth phase at the time of surgery. The growth phase of hair follicles corresponds with an increased ability to heal due to recruitment of a patients own stem cells. This study therefore aims to take advantage of the patient's own stem cell population. The 50% waxing and 50% shaving method upon each patients donor site allows us to directly compare the influence of these two methods directly on a patient-by-patient basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Patient is undergoing skin graft surgery
- •Patient is 18 years of age or older.
- •Written and informed consent provided.
排除标准
- •Participants that have been enrolled in a clinical trial within the last 3 months that would affect their ability to heal or influence hair cycle.
- •Specific hair-linked diseases, e.g. alopecia areata. (Not including androgenetic alopecia)
- •Lack of capacity to consent
- •Lymphedema
- •Malnutrition
- •Collagen disorders
- •Patients requiring grafts smaller than 5cm x 5cm
- •Patients requiring grafts wider than 10cm
- •Immunomodulation drugs
- •Patients will be excluded mid study if they develop an infection that prevents biopsy retrieval
结局指标
主要结局
Photograph Assessment
时间窗: 3 months post-surgery
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
次要结局
- Changes To Patient Microbiome (Next-Generation Sequencing)(0, 7, 14 days and 3 months.)
- Post Operative Infection incidence(3 months post surgery)
- Histological Wound Healing Score(3 months post surgery)
- Identification of Hair Cycle State via Histology(14 days post surgery)
研究者
Matthew Hardman
Chief Investigator
University of Hull