Hair Cycle Modulation To Promote Human Wound Healing

NCT ID: NCT04753060

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-26
• Study Completion Date: 2021-12-31

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.

Conditions

Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Waxing

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

Group Type: ACTIVE_COMPARATOR

Waxing

Intervention Type: PROCEDURE

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

Standard care

Standard wound preparation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Waxing

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University of Hull

OTHER

Sponsor Role: lead

Responsible Party

Matthew Hardman

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Castle Hill Hospital

Hull, East Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

RS105

Identifier Type: -

Identifier Source: org_study_id