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Study suspended temporarily due to coronavirus pandemic.
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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waxing | Active Comparator | Waxing of patients donor site who are undergoing a skingraft procedure, prior to surgery taking place. |
|
| Standard care | No Intervention | Standard wound preparation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waxing | Procedure | Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection | 7 days post surgery |
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Castle Hill Hospital | Hull | East Yorkshire | HU16 5JQ | United Kingdom |
IPD will not be shared but non-identifiable results will be published in an appropriate journal.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 14 days post surgery |
| Post Operative Infection incidence | Clinical assessment reports a presence or absence of infection | 3 months post surgery |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |