Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement

• Status: Unknown status
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase IIa open, randomised, single and parallel group, therapy controlled, single centre study, which has been divided into 3 sequential phases, which are designed to study respectively, (a) the time taken to achieve surface anaesthesia, (b) the extent of post-operative pain relief and (c) the depth and quality of anaesthesia during a leg ulcer surgical debridement procedure

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Ethics UK Ltd
• Collaborators: ProTherax Ltd; Welsh Wound Innovation Centre Ltd
• Treatments: Acetaminophen; Bupivacaine; Cetrimonium; Epinephrine; Epinephryl borate; Ibuprofen; Lidocaine; Lidocaine, Prilocaine Drug Combination; Racepinephrine

Criteria

Inclusion Criteria:

• Male and female patients aged over 18 years of age, with a chronic leg ulcer of arterial, venous, mixed aetiology or lymphoedema willing and able to provide informed consent and comply with study procedures.

• Presence of slough, necrotic or unhealthy tissue that requires removal by surgical (sharp) debridement

• Study wound that is 2-30 cm2 in regards surface area and has been present for 1-60 months.

• Presence of acute, non-cyclic pain experienced by the patient following a previous debridement. A baseline pain score (prior to any administration of treatment) should be >50mm on a 100mm visual analogue scale

Exclusion Criteria:

• Patients with an acute or chronic infectious skin disease

• Wound bed with exposed bone, tendon or fascia

• Patients with any anaesthetic allergy or intolerance of local anaesthetics or hypersensitivity to any of the ingredients of the Tri-Solfen or EMLA product

• Patients with cellulitis and/or osteomyelitis

• Patients with porphyria

• Patients with abnormal thyroid function including thyrotoxicosis

• Patients with established ventricular fibrillation, cardiac dilatation (severe angina pectoris, obstructive cardiomyopathy), coronary insufficiency, including angina, organic brain disease or atherosclerosis.

• Patients with clinically significant hepatic or renal insufficiency (glomerular filtration rate <30mL per minute)

• Patients receiving more than 2 week's treatment with immunosuppressive agents in the past 3 months.

• Patients receiving oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located.

• Any investigational drug use within 30 days

• Severe malnutrition, as judged by the investigator

• Patients who, in the opinion of the investigator, have an existing condition that would compromise their partcipation and follow up in this study

• Patients who have, or are suspected of having any underlying or skin malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.

• History of radiation at the study site

• Any other conditions that could impede wound healing

• Patients receiving concomitant medicines including, Carbemazepines, Rifampicin, Phenytoin, Griseofulvin, Phenobarbitone, and Sulphonylureas