Hair Cycle Modulation To Promote Human Wound Healing

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.

Study Overview

• Status: Suspended
• Conditions: Wounds
• Intervention / Treatment: Procedure: Waxing

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU16 5JQ
      • Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Hull
• Collaborators: National Health Service, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2019
• Primary Completion (Actual): February 21, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Wound; Hair Follicle
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RS105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared but non-identifiable results will be published in an appropriate journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No