Management of pain from donor sites in burns subjects undergoing skin grafts. Skin and Connective Tissue Diseases burns subjects undergoing skin grafts
Conditions
Sponsors
Plethora Solutions Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II) with burns that require skin grafts 2. Scheduled to have skin grafted from one or two donor sites. 3. Aged 18 - 75 years inclusive 4. Normal clinical examination (except for burns) 5. Able to understand and complete the VAPS form 6. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Skin grafted from three or more donor sites 2. Receipt of another investigational product within 3 months prior to screening 3. Known hypersensitivity to amide-type local anaesthetics, or other known drug allergies 4. Requirement for amide local anaesthetics pre- or intra-operatively. Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn 5. Clinically relevant abnormality on ECG, in the opinion of the investigator, such as prolonged QTc 6. History of alcohol or drug abuse 7. Clinically significant abnormal blood biochemistry or haematology, in the opinion of the investigator 8. History of psychiatric illness, from vulnerable groups, or have learning difficulties. 9. Female subjects who are pregnant or lactating 10. Sexually active females who are of child-bearing potential (<2 years post menopausal) and not using a reliable method of contraception (oral, injectable or implantable contraceptives, barrier methods of contraception, or surgically sterile) 11. Currently taking, or have taken within the 2 weeks prior to screening, any of the following medications: acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates (including glyceryl trinitrate), nitrites, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, or sulfonamides 12. Have taken paracetamol within 2 hours of receiving study treatment 13. Known liver disease, known renal disease or heart failure Additional Exclusion Criterion for Part 2: 14. Size of donor site(s) exceeds the area that can be covered by the maximum dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of PSD502 with placebo in relieving pain, as assessed by visual analogue pain scale (VAPS), from skin graft donor sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the safety and tolerability of PSD502 applied to skin graft donor sites 2. To characterise the preliminary pharmacokinetics of PSD502 3. To evaluate and compare the effect of PSD502 with placebo on morphine requirements | — |
Countries
United Kingdom
Outcome results
None listed