Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

Study Overview
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Brief Summary
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Acute pain may occur due to trauma, surgery, infection, disruption of blood circulation or when there is tissue injury. It can be managed using analgesics and conduction anaesthesia, which may be preferable because of superior pain control and fewer side effects. Lidocaine hydrochloride is used topically to relieve itching, burning and pain from skin inflammation. This multicentric observational study is aimed to evaluate the relief gained with lidocaine hydrochloride (ORTODERMINA®) on wound pain in patients with painful wounds and to collect safety information on this treatment.

Detailed Description
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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.

Official Title
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Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

Conditions
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Wound Healing Disorder

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lidocaine Hydrochloride|As per clinical practice, a local treatment with ORTODERMINA® over a 14-day period (once a day) was prescribed. ORTODERMINA® contains 5% of lidocaine hydrochloride.|

What is the study measuring?
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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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study | 15 days, starting from informed consent signature up to the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, pain, lidocaine