Wounds InjuriesPhase 2NCT03865147
Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement
A Phase 2 study testing Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), EMLA cream and Post Operative Analgesia (Paracetamol, Ibuprofen) in people with Wounds Injuries and Anesthesia, Local, run by Medical Ethics UK Ltd at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds Injuries, Anesthesia, Local
- What is being tested?
- Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), EMLA cream and Post Operative Analgesia (Paracetamol, Ibuprofen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2019to 30 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Welsh Wound Innovation Centre
Cardiff, Wales, CF72 8UX
Keith Harding, CBE FRCGP FRCP FRCS FLSW, +44 (0)1443 443870, Keith.Harding@wwic.wales
About this study
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
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
Read the detailed description
As part of the study, patients with leg ulcers (venous, arterial, mixed aetiology or lymphoedema) requiring surgical debridement will attend 4 visits to the study centre (Day 0, Day 1, Day 7 and Day 14). After informed consent and screening for inclusion / exclusion criteria patients will be managed as follows:
Phase 1 (N=10 patients): This is a pilot (non-comparative) phase designed to assess safety, pharmacokinetics and achievement of clinically acceptable levels of surface analgesia for Tri-Solfen in the intended patient population, prior to surgical wound debridement. Prior to surgical debridement all patients will have a single application of the Tri-Solfen product 2mL/10cm2 wound area) administered. The product will be allowed to remain in contact with the wound bed for 1 minute and surface anaesthesia will then be tested by needle-stick for up to 30 minutes after application (at 1, 3, 5, 10, 20 and 30 minutes, i.e. testing will stop when the needle stick can no longer be felt). In parallel serial blood draws of 10mL will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application to determine systemic absorption of lidocaine and bupivacaine.
Surgical debridement will proceed after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient. Pain assessments will be carried out during the procedure and at 2 min, 30 min, 1 hour, 6 hrs and 24 hours after the procedure is complete.
Phase 2 (N=40 patients; 20 per group): This is a comparative phase of Tri-Solfen vs standard of care in the management of post-operative analgesia. All patients will receive standard of care (i.e. 60 mins of EMLA Cream) to anaesthetise the leg ulcer and will undergo surgical debridement after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient.
On completion of surgical debridement, patients will be randomised to one of two groups:
- Group 1: a single application of Tri-Solfen (2mL/10cm2) with standard of care post-surgical analgesia (e.g. paracetamol, NSAID or opiate) provided as required (N=20), or
- Group 2: standard of care post-surgical analgesia (e.g. paracetamol, NSAID or opiate) as required only (N=20).
Serial blood draws of 10mL from the Tri-Solfen group will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application of Tri-Solfen to determine systemic absorption of lidocaine and bupivacaine. Pain assessments and extent of analgesia required will also be carried out at 2 min, 30 min, 1 hour, 6 hrs and 24 hours.
Phase 3 (N=40 patients; 20 per group). Since debridement of the wound may result in removal of surface anaesthesia, this phase is intended to compare the quality of anaesthesia from standard of care (single application of EMLA cream from administration over 60 minutes) with one application of Tri-Solfen administered pre-surgical debridement, and one application on completion of surgery. Safety and quality of anaesthesia / analgesia in the intended patient population before, during and after the surgical debridement procedure will be monitored.
Prior to debridement, patients will be randomised to either:
- Group 1: Tri-Solfen (2mL/10cm2) administered once prior to wound debridement and once on completion of surgical debridement (N=20)
- Group 2: EMLA cream (1-2g /10cm2). administered to the wound for 60 minutes under an occlusive dressing (N=20).
In both groups, the time taken to achieve clinically acceptable surface anaesthesia required to perform the surgical procedure will be assessed using a needle-stick at the wound site. In patients receiving Tri-Solfen, this will be performed at 1, 3, 5, 10, 20 and 30 minutes after application of the Tri-Solfen - assessments will stop when the needle can no longer be detected by the patient. Needle stick testing will also be undertaken immediately following removal of EMLA cream after 60 minutes in EMLA-treated patients to provide a baseline comparator of pre-operative anaesthetic efficacy.
Surgical debridement will proceed only after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient. Pain assessments will be carried out during the procedure and at 2 min, 30 min, 1 hour, 6 hrs and 24 hours after the procedure is complete.
Serial blood draws of 10mL from the Tri-Solfen group will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application of the first dose of Tri-Solfen to determine systemic absorption of lidocaine and bupivacaine from multiple dosing.
All Phases Patients will be followed up for two weeks to confirm that the use of the Tri-Solfen (or EMLA) product do not adversely affect wound healing and to assess the incidence of adverse events, including wound infections
- Conditions
- Wounds Injuries, Anesthesia, Local
- Being tested
- Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), EMLA cream, Post Operative Analgesia (Paracetamol, Ibuprofen)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)Drug
Investigational Drug
EMLA creamDrug
Active Comparator
Post Operative Analgesia (Paracetamol, Ibuprofen)Drug
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 open, pilot phase | Experimental | A pilot group of 10 patients who will receive Tri-Solfen only (non-randomised) once, prior to debridement Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: EMLA cream; Drug: Post Operative Analgesia (Paracetamol, Ibuprofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lidocaine Maximum Plasma Concentration
Blood draws to determine systemic levels of lidocaine
Measured: Day 0 - Day 1
Bupivacaine Maximum Plasma Concentration
Blood draws to determine systemic levels of bupivacaine
Measured: Day 0 - Day 1
Local tolerability assessments
Numerical Rating Scale (0-4) for itch, burn, pain, oedema, exudate, inflammation
Measured: Day 0 - Day 1
Local tolerability assessments
Numerical Rating Scale (0-1) for presence of bleeding and wound infection
Measured: Day 0 - Day 1
Secondary outcomes (5)
Pain on Application
Numerical Rating Scale (0-3) of none, mild, moderate, severe
Measured: 1 minute
Time taken to achieve clinically acceptable surface anaesthesia
Perception of needle-stick at the wound site
Measured: 0-30 minutes after application
Pain during wound debridement
Verbal pain assessment by the patient during wound debridement
Measured: 10-15 minutes
Clinical adequacy of wound debridement
Percentage of wound debrided
Measured: On completion of surgery
Duration of post-operative pain relief
Assessment of the duration of post-operative pain relief using a VAS
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Jan 2019
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IIA, open, randomised, single and parallel group, therapy controlled single centre study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Ethics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProTherax Ltd, Welsh Wound Innovation Centre Ltd
- Responsible party
- Sponsor
- Investigators
- Keith Harding, Principal investigator, Welsh Wound Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865147
- Sponsor's protocol ID
- TriSolfen_H_01
- Other IDs
- 2018-000613-21, 2018
- Status last verified
- Mar 2019
- First submitted
- 2 May 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03865147
- Acronym / sponsor ID
- TriSolfen_H_01
- Conditions
- Wounds Injuries, Anesthesia, Local
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical Ethics UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- ProTherax Ltd, Welsh Wound Innovation Centre Ltd
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
As part of the study, patients with leg ulcers (venous, arterial, mixed aetiology or lymphoedema) requiring surgical debridement will attend 4 visits to the study centre (Day 0, Day 1, Day 7 and Day 14). After informed consent and screening for inclusion / exclusion criteria patients will be managed as follows:
Phase 1 (N=10 patients): This is a pilot (non-comparative) phase designed to assess safety, pharmacokinetics and achievement of clinically acceptable levels of surface analgesia for Tri-Solfen in the intended patient population, prior to surgical wound debridement. Prior to surgical debridement all patients will have a single application of the Tri-Solfen product 2mL/10cm2 wound area) administered. The product will be allowed to remain in contact with the wound bed for 1 minute and surface anaesthesia will then be tested by needle-stick for up to 30 minutes after application (at 1, 3, 5, 10, 20 and 30 minutes, i.e. testing will stop when the needle stick can no longer be felt). In parallel serial blood draws of 10mL will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application to determine systemic absorption of lidocaine and bupivacaine.
Surgical debridement will proceed after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient. Pain assessments will be carried out during the procedure and at 2 min, 30 min, 1 hour, 6 hrs and 24 hours after the procedure is complete.
Phase 2 (N=40 patients; 20 per group): This is a comparative phase of Tri-Solfen vs standard of care in the management of post-operative analgesia. All patients will receive standard of care (i.e. 60 mins of EMLA Cream) to anaesthetise the leg ulcer and will undergo surgical debridement after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient.
On completion of surgical debridement, patients will be randomised to one of two groups:
- Group 1: a single application of Tri-Solfen (2mL/10cm2) with standard of care post-surgical analgesia (e.g. paracetamol, NSAID or opiate) provided as required (N=20), or
- Group 2: standard of care post-surgical analgesia (e.g. paracetamol, NSAID or opiate) as required only (N=20).
Serial blood draws of 10mL from the Tri-Solfen group will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application of Tri-Solfen to determine systemic absorption of lidocaine and bupivacaine. Pain assessments and extent of analgesia required will also be carried out at 2 min, 30 min, 1 hour, 6 hrs and 24 hours.
Phase 3 (N=40 patients; 20 per group). Since debridement of the wound may result in removal of surface anaesthesia, this phase is intended to compare the quality of anaesthesia from standard of care (single application of EMLA cream from administration over 60 minutes) with one application of Tri-Solfen administered pre-surgical debridement, and one application on completion of surgery. Safety and quality of anaesthesia / analgesia in the intended patient population before, during and after the surgical debridement procedure will be monitored.
Prior to debridement, patients will be randomised to either:
- Group 1: Tri-Solfen (2mL/10cm2) administered once prior to wound debridement and once on completion of surgical debridement (N=20)
- Group 2: EMLA cream (1-2g /10cm2). administered to the wound for 60 minutes under an occlusive dressing (N=20).
In both groups, the time taken to achieve clinically acceptable surface anaesthesia required to perform the surgical procedure will be assessed using a needle-stick at the wound site. In patients receiving Tri-Solfen, this will be performed at 1, 3, 5, 10, 20 and 30 minutes after application of the Tri-Solfen - assessments will stop when the needle can no longer be detected by the patient. Needle stick testing will also be undertaken immediately following removal of EMLA cream after 60 minutes in EMLA-treated patients to provide a baseline comparator of pre-operative anaesthetic efficacy.
Surgical debridement will proceed only after a needle stick can no longer be felt and will cease when either the wound bed is deemed to be clean and free from necrotic tissue in the presence of punctate bleeding or where pain increases to an unacceptable level as defined by the patient. Pain assessments will be carried out during the procedure and at 2 min, 30 min, 1 hour, 6 hrs and 24 hours after the procedure is complete.
Serial blood draws of 10mL from the Tri-Solfen group will be taken at 2min, 30min, 1 hr, 2hrs and 6hrs after application of the first dose of Tri-Solfen to determine systemic absorption of lidocaine and bupivacaine from multiple dosing.
All Phases Patients will be followed up for two weeks to confirm that the use of the Tri-Solfen (or EMLA) product do not adversely affect wound healing and to assess the incidence of adverse events, including wound infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Phase IIA, open, randomised, single and parallel group, therapy controlled single centre study
| Arm | Type | Receives |
|---|---|---|
| Phase 1 open, pilot phase | Experimental | Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)A pilot group of 10 patients who will receive Tri-Solfen only (non-randomised) once, prior to debridement |
| Phase 2 - Tri-Solfen | Experimental | Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), Drug: EMLA creamA 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. |
| Phase 2 - Standard Care | Active comparator | Drug: EMLA cream, Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)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. |
| Phase 3 - Tri-Solfen | Experimental | Drug: Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)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. |
| Phase 3 - EMLA | Active comparator | Drug: EMLA cream, Drug: Post Operative Analgesia (Paracetamol, Ibuprofen)A group of 20 patients who will receive EMLA Cream (60-minute application) prior to surgical debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)Investigational Drug | Drug | Phase 1 open, pilot phase, Phase 2 - Tri-Solfen, Phase 3 - Tri-Solfen |
| EMLA creamActive Comparator | Drug | Phase 2 - Standard Care, Phase 2 - Tri-Solfen, Phase 3 - EMLA |
| Post Operative Analgesia (Paracetamol, Ibuprofen)Standard of Care | Drug | Phase 2 - Standard Care, Phase 3 - EMLA, Phase 3 - Tri-Solfen |
Primary outcome
Lidocaine Maximum Plasma Concentration
Time frame: Day 0 - Day 1
Blood draws to determine systemic levels of lidocaine
Bupivacaine Maximum Plasma Concentration
Time frame: Day 0 - Day 1
Blood draws to determine systemic levels of bupivacaine
Local tolerability assessments
Time frame: Day 0 - Day 1
Numerical Rating Scale (0-4) for itch, burn, pain, oedema, exudate, inflammation
Local tolerability assessments
Time frame: Day 0 - Day 1
Numerical Rating Scale (0-1) for presence of bleeding and wound infection
5 secondary outcomes
Pain on Application
Time frame: 1 minute
Time taken to achieve clinically acceptable surface anaesthesia
Time frame: 0-30 minutes after application
Pain during wound debridement
Time frame: 10-15 minutes
Clinical adequacy of wound debridement
Time frame: On completion of surgery
Duration of post-operative pain relief
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Harding principal investigator
Welsh Wound Innovation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide), EMLA cream and Post Operative Analgesia (Paracetamol, Ibuprofen) in people with Wounds Injuries and Anesthesia, Local, run by Medical Ethics UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David M Fairlamb (+44 12474 561815, davidfairlamb@protherax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lidocaine Maximum Plasma Concentration (time frame: Day 0 - Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.