- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03720119
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute pain can be managed using analgesics and conduction anaesthesia which may be preferable because of superior pain control and fewer side effects. In this contest, lidocaine hydrochloride (ORTODERMINA®) plays an important role in pain management during wound healing. The properties of ORTODERMINA® and its ability to maintain an adequate level of active drug over the lesion allow a persistent anaesthetic effect. ORTODERMINA® is a drug for topical application in the form of cream, with a high safety profile. However, although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anaesthetic agent administered.
This multicentric observational study is aimed to evaluate the relief gained with ORTODERMINA® on wound pain in patients with painful wounds and to collect safety information on this treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pisa, Italy
- Azienda Ospedaliero Pisana
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Trieste, Italy
- Ospedali Riuniti Trieste
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >18 years
- Patients with painful exuding wounds >1 cm2 that includes painful exuding ulcers and pressure ulcers grade II [according to National Pressure Ulcer Advisory Panel (NPUAP) classification]
- Patients available and able to return to the study site for the scheduled visits
- Patients who gave written informed consent to take part into the study
Exclusion Criteria:
- Patients with ulcer infected, discoloured, odorous, pressure ulcer grade I, III, or IV (according to NPUAP classification)
- Diabetic foot ulcer
- Patients with contraindication or known allergy to drug's components
- Patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies
- Patients who are pregnant or lactating.
- Patients with vascular disorders (mainly arteriopathies)
- Patients known as alcohol or drug abusers.
- Patients currently participating in a clinical study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Time Frame: Every day for 15 days
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The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief). Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0. |
Every day for 15 days
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
Time Frame: Every day for 15 days
|
The evaluation of the pain intensity was based on a 11-point Numerical Pain Rating Scale (NPRS score from 0= no pain to 10= the most intense pain imaginable). Patients recorded the NPRS score every day of treatment in their diary. The improvement in the pain intensity is defined as a decrease in NPRS scores from baseline to the end of treatment. |
Every day for 15 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 15 days, starting from informed consent signature up to the end of the study
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Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study
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15 days, starting from informed consent signature up to the end of the study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Romanelli, MD, Azienda Ospedaliero, Universitaria Pisana
- Study Chair: Elia Ricci, MD, Clinica San Luca, Torino
Publications and helpful links
General Publications
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556.
- Dallam L, Smyth C, Jackson BS, Krinsky R, O'Dell C, Rooney J, Badillo C, Amella E, Ferrara L, Freeman K. Pressure ulcer pain: assessment and quantification. J Wound Ostomy Continence Nurs. 1995 Sep;22(5):211-5; discussion 217-8. doi: 10.1097/00152192-199509000-00007.
- Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
- Chase SK, Melloni M, Savage A. A forever healing: the lived experience of venous ulcer disease. J Vasc Nurs. 1997 Jun;15(2):73-8. doi: 10.1016/s1062-0303(97)90004-2.
- Briggs M, Closs SJ. Patients' perceptions of the impact of treatments and products on their experience of leg ulcer pain. J Wound Care. 2006 Sep;15(8):333-7. doi: 10.12968/jowc.2006.15.8.26941.
- Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004846. doi: 10.1002/14651858.CD004846.pub2.
- Santiago S, Ferrer T, Espinosa ML. Neurophysiological studies of thin myelinated (A delta) and unmyelinated (C) fibers: application to peripheral neuropathies. Neurophysiol Clin. 2000 Feb;30(1):27-42. doi: 10.1016/S0987-7053(00)88865-6.
- Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials. 1997 Dec;18(6):530-45; discussion 546-9. doi: 10.1016/s0197-2456(97)00008-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- SINALGO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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