Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement
Wounds Injuries, Anesthesia, Local
About this trial
This is an interventional treatment trial for Wounds Injuries
Eligibility 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
Sites / Locations
- Welsh Wound Innovation CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Phase 1 open, pilot phase
Phase 2 - Tri-Solfen
Phase 2 - Standard Care
Phase 3 - Tri-Solfen
Phase 3 - EMLA
A pilot group of 10 patients who will receive Tri-Solfen only (non-randomised) once, prior to debridement
A group of 20 patients who will receive EMLA cream (60 minute application) to anaesthetise the leg ulcer prior to surgical wound debridement, followed on completion of surgery by a single application of Tri-Solfen.
A group of 20 patients who will receive EMLA Cream (60 minute application) to anaesthetise the leg ulcer prior to surgical wound debridement, followed on completion of surgery by standard of care post-operative analgesia.
A group of 20 patients who will receive two applications of Tri-Solfen (2mL/10cm2), once prior to debridement and once on completion of the procedure.
A group of 20 patients who will receive EMLA Cream (60-minute application) prior to surgical debridement