Clinical trial NCT04753060: Hair Cycle Modulation To Promote Human Wound Healing
Official title: Hair Cycle Modulation To Promote Human Wound Healing
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Wounds
Keywords: Wound
Hair Follicle
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2021-02-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing skin graft surgery
* Patient is 18 years of age or older.
* Written and informed consent provided.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Photograph Assessment
timeFrame: 7 days post-surgery
measure: Photograph Assessment
timeFrame: 14 days post-surgery
measure: Photograph Assessment
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Post Operative Infection incidence
timeFrame: 7 days post surgery
measure: Post Operative Infection incidence
timeFrame: 14 days post surgery
measure: Post Operative Infection incidence
timeFrame: 3 months post surgery
measure: Changes To Patient Microbiome (Next-Generation Sequencing)
timeFrame: 0, 7, 14 days and 3 months.
measure: Histological Wound Healing Score
timeFrame: Day 0
measure: Histological Wound Healing Score
timeFrame: 7 days post surgery
measure: Histological Wound Healing Score
timeFrame: 14 days post surgery
measure: Histological Wound Healing Score
timeFrame: 3 months post surgery
measure: Identification of Hair Cycle State via Histology
timeFrame: Day 0
measure: Identification of Hair Cycle State via Histology
timeFrame: 7 days post surgery
measure: Identification of Hair Cycle State via Histology
timeFrame: 14 days post surgery
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
Study officials:
References: