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Hair Cycle Modulation To Promote Human Wound Healing

Hair Cycle Modulation To Promote Human Wound Healing

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04753060
Enrollment
11
Registered
2021-02-12
Start date
2019-07-26
Completion date
2021-12-31
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

Wound, Hair Follicle

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.

Interventions

PROCEDUREWaxing

Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.

Sponsors

National Health Service, United Kingdom
CollaboratorOTHER_GOV
University of Hull
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Photograph Assessment7 days post-surgeryDigital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.

Secondary

MeasureTime frameDescription
Post Operative Infection incidence7 days post surgeryClinical assessment reports a presence or absence of infection
Changes To Patient Microbiome (Next-Generation Sequencing)0, 7, 14 days and 3 months.Changes to skin microbiome as compared to day 0 using next-generation sequencing.
Histological Wound Healing ScoreDay 0H&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.
Identification of Hair Cycle State via HistologyDay 0Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026