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

NCT03865147 | Unknown Phase 2

• 2 other identifiers: TriSolfen_H_012018-000613-21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Wounds Injuries; Anesthesia, Local

Outcome Measures

Primary Outcomes (4)

• Lidocaine Maximum Plasma Concentration

  Blood draws to determine systemic levels of lidocaine

  Day 0 - Day 1

• Bupivacaine Maximum Plasma Concentration

  Blood draws to determine systemic levels of bupivacaine

  Day 0 - Day 1

• Local tolerability assessments

  Numerical Rating Scale (0-4) for itch, burn, pain, oedema, exudate, inflammation

  Day 0 - Day 1

• Local tolerability assessments

  Numerical Rating Scale (0-1) for presence of bleeding and wound infection

  Day 0 - Day 1

Secondary Outcomes (5)

• Pain on Application

  1 minute

• Time taken to achieve clinically acceptable surface anaesthesia

  0-30 minutes after application

• Pain during wound debridement

  10-15 minutes

• Clinical adequacy of wound debridement

  On completion of surgery

• Duration of post-operative pain relief

  Up to 24 hours

Study Arms (5)

Phase 1 open, pilot phase

EXPERIMENTAL

A pilot group of 10 patients who will receive Tri-Solfen only (non-randomised) once, prior to debridement

Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)

Phase 2 - Tri-Solfen

EXPERIMENTAL

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.

Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide); Drug: EMLA cream

Phase 2 - Standard Care

ACTIVE COMPARATOR

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.

Drug: EMLA cream; Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)

Phase 3 - Tri-Solfen

EXPERIMENTAL

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.

Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide); Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)

Phase 3 - EMLA

ACTIVE COMPARATOR

A group of 20 patients who will receive EMLA Cream (60-minute application) prior to surgical debridement

Drug: EMLA cream; Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)

Interventions

Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide) DRUG

Investigational Drug

Phase 1 open, pilot phase; Phase 2 - Tri-Solfen; Phase 3 - Tri-Solfen

EMLA cream DRUG

Active Comparator

Phase 2 - Standard Care; Phase 2 - Tri-Solfen; Phase 3 - EMLA

Post Operative Analgesia (Paracetamol, Ibuprofen) DRUG

Standard of Care

Phase 2 - Standard Care; Phase 3 - EMLA; Phase 3 - Tri-Solfen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Ethics UK Ltd: lead
• ProTherax Ltd: collaborator
• Welsh Wound Innovation Centre Ltd: collaborator

Study Sites (1)

Welsh Wound Innovation Centre

Cardiff, Wales, CF72 8UX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Lidocaine; Bupivacaine; Epinephrine; Cetrimonium; Lidocaine, Prilocaine Drug Combination; Acetaminophen; Ibuprofen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cetrimonium Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Prilocaine; Drug Combinations; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Keith Harding

  Welsh Wound Innovation Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Fairlamb

CONTACT

+44 12474 561815; davidfairlamb@protherax.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase IIA, open, randomised, single and parallel group, therapy controlled single centre study

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: March 6, 2019
• Study Start: January 15, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)