Hair Cycle Modulation To Promote Human Wound Healing

Wounds Clinical Trial

Official title:

Hair Cycle Modulation To Promote Human Wound Healing

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04753060
• Other study ID #: RS105
• Status: Suspended
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 11
• Est. completion date: December 31, 2021
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Intervention

Procedure:
• Waxing
Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Hull	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Post Operative Infection incidence	Clinical assessment reports a presence or absence of infection	7 days post surgery
Secondary	Post Operative Infection incidence	Clinical assessment reports a presence or absence of infection	14 days post surgery
Secondary	Post Operative Infection incidence	Clinical assessment reports a presence or absence of infection	3 months post surgery
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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