Assessment of cutaneous wound healing in healthy volunteers with and without skin substitute using electrical stimulation Skin and Connective Tissue Diseases
Conditions
Interventions
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
Sponsors
Accel-Heal® Technologies Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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)).
Exclusion criteria
Exclusion criteria: 1. Subjects who do not give consent or withdraw their consent to take part in the study. 2. Subjects of either gender who are less than 18 years old. 3. Subjects who have a history of keloid scarring. 4. Subjects who are pregnant or planning to conceive in the next 3 months. 5. Subjects who have a chronic or active skin disorder which may be considered to adversely affect the healing rate of the acute wound by the investigator. 6. Subjects with any likely wound healing impairment due to a clinically significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including: 7. Rheumatoid arthritis 8. Chronic renal impairment 9. Diabetes Mellitus 10. Significant hepatic impairment 11. Inadequately or uncontrolled congestive heart failure 12. Malignancy – diagnosed or treated within the past 5 years. 13. Immunosuppressive, radiation or chemotherapy within the last three months. 14. Subjects who take medication known to alter/influence the healing of skin (e.g. steroids) 15. Subjects who are receiving formal oral anticoagulant therapy (warfarin). 16. Subjects who have received any investigational drugs, or have taken any in the previous month prior to day 0. 17. Subjects who have evidence of drug abuse. 18. Subjects who have had or are known to have hepatitis B or hepatitis C infection including carriers of hepatitis B surface antigen, hepatitis B core antibodies or hepatitis C antibodies. Previous vaccination against hepatitis B or C is not excluded. 19. Subjects who have previously had a positive result to the HIV antibody test, or admit to belong to a high risk group. 20. Any subject, who in the opinion of the investigator is unable to fully understand the requirements of the trial, consent or is unable to return for follow-up visits and complete the trial. 21. Subjects who become systemically unwell during the research process due to external study causes. 22. Subjects who have been involved in other studies in the past month prior to day 0 must discuss the exact details of the previous studies prior to a decision being made on eligibility for inclusion in this trial. 23. Subjects with known severe allergies to antibiotics as the skin substitutes may contain antibiotic residuals from processing. 24. Patients who are allergic to other amide local anaesthetics. 25. Previous MRSA colonisation or infection 26. Any bleeding disorders 27. Subjects with any heart conditions 28. Subjects who have a pacemaker inserted 29. Subjects who have epilepsy 30. Subjects who currently have cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed