Hair Cycle Modulation To Promote Human Wound Healing

Study Overview
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Brief Summary
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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.

Official Title
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Hair Cycle Modulation To Promote Human Wound Healing

Conditions
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Wounds

Intervention / Treatment
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* Procedure: Waxing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Waxing<br>Waxing of patients donor site who are undergoing a skingraft procedure, prior to surgery taking place. | Procedure: Waxing<br>* Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.<br>|
| No Intervention: Standard care<br>Standard wound preparation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photograph Assessment | Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome. | 7 days post-surgery | 
| Photograph Assessment | Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome. | 14 days post-surgery | 
| Photograph Assessment | Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome. | 3 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection | 7 days post surgery | 
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection | 14 days post surgery | 
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection | 3 months post surgery | 
| Changes To Patient Microbiome (Next-Generation Sequencing) | Changes to skin microbiome as compared to day 0 using next-generation sequencing. | 0, 7, 14 days and 3 months. | 
| Histological Wound Healing Score | H&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome. | Day 0 | 
| Histological Wound Healing Score | H&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome. | 7 days post surgery | 
| Histological Wound Healing Score | H&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome. | 14 days post surgery | 
| Histological Wound Healing Score | H&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome. | 3 months post surgery | 
| Identification of Hair Cycle State via Histology | Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles. | Day 0 | 
| Identification of Hair Cycle State via Histology | Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles. | 7 days post surgery | 
| Identification of Hair Cycle State via Histology | Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles. | 14 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, Hair Follicle