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Hair Cycle Modulation To Promote Human Wound Healing

Primary Purpose

Wounds

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Waxing
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds focused on measuring Wound, Hair Follicle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Castle Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Waxing

Standard care

Arm Description

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

Standard wound preparation

Outcomes

Primary Outcome Measures

Photograph Assessment
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
Photograph Assessment
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
Photograph Assessment
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.

Secondary Outcome Measures

Post Operative Infection incidence
Clinical assessment reports a presence or absence of infection
Post Operative Infection incidence
Clinical assessment reports a presence or absence of infection
Post Operative Infection incidence
Clinical assessment reports a presence or absence of infection
Changes To Patient Microbiome (Next-Generation Sequencing)
Changes to skin microbiome as compared to day 0 using next-generation sequencing.
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.
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.
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.
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.
Identification of Hair Cycle State via Histology
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.
Identification of Hair Cycle State via Histology
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.
Identification of Hair Cycle State via Histology
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.

Full Information

First Posted
February 2, 2021
Last Updated
February 9, 2021
Sponsor
University of Hull
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT04753060
Brief Title
Hair Cycle Modulation To Promote Human Wound Healing
Official Title
Hair Cycle Modulation To Promote Human Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Suspended
Why Stopped
Study suspended temporarily due to coronavirus pandemic.
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hull
Collaborators
National Health Service, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
Wound, Hair Follicle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waxing
Arm Type
Active Comparator
Arm Description
Waxing of patients donor site who are undergoing a skingraft procedure, prior to surgery taking place.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard wound preparation
Intervention Type
Procedure
Intervention Name(s)
Waxing
Intervention Description
Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.
Primary Outcome Measure Information:
Title
Photograph Assessment
Description
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
Time Frame
7 days post-surgery
Title
Photograph Assessment
Description
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
Time Frame
14 days post-surgery
Title
Photograph Assessment
Description
Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.
Time Frame
3 months post-surgery
Secondary Outcome Measure Information:
Title
Post Operative Infection incidence
Description
Clinical assessment reports a presence or absence of infection
Time Frame
7 days post surgery
Title
Post Operative Infection incidence
Description
Clinical assessment reports a presence or absence of infection
Time Frame
14 days post surgery
Title
Post Operative Infection incidence
Description
Clinical assessment reports a presence or absence of infection
Time Frame
3 months post surgery
Title
Changes To Patient Microbiome (Next-Generation Sequencing)
Description
Changes to skin microbiome as compared to day 0 using next-generation sequencing.
Time Frame
0, 7, 14 days and 3 months.
Title
Histological Wound Healing Score
Description
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.
Time Frame
Day 0
Title
Histological Wound Healing Score
Description
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.
Time Frame
7 days post surgery
Title
Histological Wound Healing Score
Description
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.
Time Frame
14 days post surgery
Title
Histological Wound Healing Score
Description
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.
Time Frame
3 months post surgery
Title
Identification of Hair Cycle State via Histology
Description
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.
Time Frame
Day 0
Title
Identification of Hair Cycle State via Histology
Description
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.
Time Frame
7 days post surgery
Title
Identification of Hair Cycle State via Histology
Description
Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.
Time Frame
14 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Castle Hill Hospital
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared but non-identifiable results will be published in an appropriate journal.

Learn more about this trial

Hair Cycle Modulation To Promote Human Wound Healing

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