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

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ClinicalTrials.gov Identifier: NCT03865147
Recruitment Status : Unknown
Verified March 2019 by Medical Ethics UK Ltd.
Recruitment status was:  Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
ProTherax Ltd
Welsh Wound Innovation Centre Ltd
Information provided by (Responsible Party):
Medical Ethics UK Ltd

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

Condition or disease Intervention/treatment Phase
Wounds Injuries Anesthesia, Local Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide) Drug: EMLA cream Drug: Post Operative Analgesia (Paracetamol, Ibuprofen) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase IIA, open, randomised, single and parallel group, therapy controlled single centre study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomised, Parallel Group Controlled, Single Centre Safety Study to Assess the Safety and Efficacy of Tri-Solfen in Providing Anaesthesia Prior to Surgical Debridement of Leg Ulcers and Post-operative Pain Relief
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 open, pilot phase
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)
Investigational Drug

Experimental: Phase 2 - 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 a single application of Tri-Solfen.
Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)
Investigational Drug

Drug: EMLA cream
Active Comparator

Active Comparator: Phase 2 - Standard Care
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
Active Comparator

Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)
Standard of Care

Experimental: Phase 3 - Tri-Solfen
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)
Investigational Drug

Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)
Standard of Care

Active Comparator: Phase 3 - EMLA
A group of 20 patients who will receive EMLA Cream (60-minute application) prior to surgical debridement
Drug: EMLA cream
Active Comparator

Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)
Standard of Care




Primary Outcome Measures :
  1. Lidocaine Maximum Plasma Concentration [ Time Frame: Day 0 - Day 1 ]
    Blood draws to determine systemic levels of lidocaine

  2. Bupivacaine Maximum Plasma Concentration [ Time Frame: Day 0 - Day 1 ]
    Blood draws to determine systemic levels of bupivacaine

  3. Local tolerability assessments [ Time Frame: Day 0 - Day 1 ]
    Numerical Rating Scale (0-4) for itch, burn, pain, oedema, exudate, inflammation

  4. Local tolerability assessments [ Time Frame: Day 0 - Day 1 ]
    Numerical Rating Scale (0-1) for presence of bleeding and wound infection


Secondary Outcome Measures :
  1. Pain on Application [ Time Frame: 1 minute ]
    Numerical Rating Scale (0-3) of none, mild, moderate, severe

  2. Time taken to achieve clinically acceptable surface anaesthesia [ Time Frame: 0-30 minutes after application ]
    Perception of needle-stick at the wound site

  3. Pain during wound debridement [ Time Frame: 10-15 minutes ]
    Verbal pain assessment by the patient during wound debridement

  4. Clinical adequacy of wound debridement [ Time Frame: On completion of surgery ]
    Percentage of wound debrided

  5. Duration of post-operative pain relief [ Time Frame: Up to 24 hours ]
    Assessment of the duration of post-operative pain relief using a VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865147


Contacts
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Contact: David M Fairlamb +44 12474 561815 davidfairlamb@protherax.com

Locations
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United Kingdom
Welsh Wound Innovation Centre Recruiting
Cardiff, Wales, United Kingdom, CF72 8UX
Contact: Keith Harding, CBE FRCGP FRCP FRCS FLSW    +44 (0)1443 443870    Keith.Harding@wwic.wales   
Sponsors and Collaborators
Medical Ethics UK Ltd
ProTherax Ltd
Welsh Wound Innovation Centre Ltd
Investigators
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Principal Investigator: Keith Harding Welsh Wound Innovation Centre
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Responsible Party: Medical Ethics UK Ltd
ClinicalTrials.gov Identifier: NCT03865147    
Other Study ID Numbers: TriSolfen_H_01
2018-000613-21 ( EudraCT Number )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Acetaminophen
Cetrimonium
Ibuprofen
Lidocaine
Epinephrine
Racepinephrine
Bupivacaine
Lidocaine, Prilocaine Drug Combination
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Adrenergic alpha-Agonists