Hair Cycle Modulation To Promote Human Wound Healing

NCT04753060 | Suspended

• 1 other identifier: RS105
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Wound; Hair Follicle

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Post Operative Infection incidence

  7 days post surgery

• Post Operative Infection incidence

  14 days post surgery

• Post Operative Infection incidence

  3 months post surgery

• Changes To Patient Microbiome (Next-Generation Sequencing)

  0, 7, 14 days and 3 months.

• Histological Wound Healing Score

  Day 0

Study Arms (2)

Waxing

ACTIVE COMPARATOR

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

Procedure: Waxing

Standard care

NO INTERVENTION

Standard wound preparation

Interventions

Waxing PROCEDURE

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

Waxing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing skin graft surgery
• Patient is 18 years of age or older.
• Written and informed consent provided.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead
• National Health Service, United Kingdom: collaborator

Study Sites (1)

Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: July 26, 2019
• Primary Completion: February 21, 2020
• Study Completion: December 31, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)