Hair Cycle Modulation To Promote Human Wound Healing

University of Hull

Status: Suspended

Conditions: Wounds

Treatments: Procedure: Waxing

Study type: Interventional

Funder types: Other

Identifiers

NCT04753060

RS105

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Waxing

Active Comparator group

Description:

Waxing of patients donor site who are undergoing a skingraft procedure, prior to surgery taking place.

Treatment:

Procedure: Waxing

Standard care

No Intervention group

Description:

Standard wound preparation