The role of electrical stimulation and skin substitute in enhancing wound healing

INTERVENTION: Participants are screened, consented and recruited. Participants receive 4 x 4mm punch biopsies to both upper inner arms to create the wounds. They are independently randomised as to which arm should receive either treatment or placebo. Allocation to arm will be by a computer‐generated randomised block method. This allocation list will be held by a University of Manchester person independent of the study team. The participants will either have Active ES treatment on their Left or Right arms and this will be randomised to account for handedness. Both participants and researcher will be blinded as to which treatment is on which arm. Both Placebo/Sham device and Active ES device will look exactly the same. A member outside of the immediate research team will label the devices according to participant number on the randomisation list and the researcher will use these coded devices. Treatment: Electrical stimulation dressing Placebo: Sham electrical stimulation dressing Two wound sites will have dermal substitute applied and two left without. Wounds will be re‐biopsied with 5mm punch biopsies at day 7 and day 14. Non‐invasive measurements are taken on a weekly basis for each participants' duration of the trial. Final scar biopsies are used for histological, gene and protein analysis. CONDITION: Assessment of cutaneous wound healing in healthy volunteers with and without skin substitute using electrical stimulation ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: ; 1. Assessment of cutaneous wound healing using histological and immunohistochemical and gene studies at day 0, day 7 and day 14 (angiogenesis, inflammatory and neurogenic markers).; 2. Wound closure measured by non‐invasive devices including 3‐dimensional imaging at days 0, 3, 7, 10 and 14 and laboratory analysis including wound contraction markers such as alpha smooth muscle actin measured at days 0, 7 and 14.; 3. Angiogenesis measured by non‐invasive devices including full‐field laser perfusion imaging and dynamic optical coherence tomography at days 0, 3, 7, 10, 14 and protein and gene markers including CD31 and VEGFA on days 0, 7 and 14.; 4. Inflammation and neurogenic markers measured by immunohistochemical analysis and QRTPCR on days 0, 7 and 14.; SECONDARY OUTCOME: ; 1. Assessment of cutaneous healing using objective non‐invasive measurements on both arms on days 0, 3, 7, 10 and 14.; 2. Wound elasticity (measured by elastometer) on days 0, 3, 7, 10 and 14. Skin colour (measured by colormeter) on days 0, 3, 7, 10 and 14.; 3. Transepidermal water loss (measured by TEWL device) on days 0, 3, 7, 10 and 14.; 4. Hydration (measured by hydration probe) on days 0, 3, 7, 10 and 14. Collagen (measured by SIAscopy) on days 0, 3, 7, 10 and 14.; 5. Subjective scoring using VAS for pain, itch on days 0, 3, 7 , 10 and 14 for both arms.; INCLUSION CRITERIA: 1. Male and female subjects will be included to allow for gender demographic analysis. 2. Subjects of either gender who are 18 years and older. 3. Subjects who in the opinion of the investigator, are able to fully understand the study requirements and attend all follow‐up visits. 4. Subjects must provide written informed consent to participate in the study. 5. Subjects weighing between 40 and 150kg, with a body mass index of 20‐35kg/m2 (as described in the Quetelet’sindexQuetelet’s index – weight (kg)/height²(m)).