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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Hydrochloride | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A sample size of 70 evaluable patients is needed to test the hypothesis of an improvement in wound pain relief and a reduction in pain intensity, assuming a standardized effect size equal to 0.35, for a one-tailed test with a 5% significance level and a 90% power. A 10% of attrition rate is expected; therefore, a total number of patients to be enrolled is 78.
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| Name | Affiliation | Role |
|---|---|---|
| Marco Romanelli, MD | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Elia Ricci, MD | Clinica San Luca, Torino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Pisana | Pisa | Italy | ||||
| Ospedali Riuniti Trieste |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8006433 | Background | Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556. | |
| 7550776 | Background | 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. |
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Patients were recruited from January 27, 2015 to March 05, 2018 in three Italian hospitals in Pisa and Trieste
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Cohort | A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Cohort | A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There are missing data in some time-points | Posted | Count of Participants | Participants | Every day for 15 days |
|
15 days, from informed consent signature to the end of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Cohort | A single cohort of 78 patients with painful wounds >1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment | Pain Lower part of the Leg |
There are not limitations or caveats to be reported for this clinical investigation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Laura Patrucco | Sofar | +39 02909362 | 1 | laura.patrucco@sofarfarm.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2015 | Oct 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Trieste |
| Italy |
| 23388350 | Background | 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. |
| 9238945 | Background | 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. |
| 17001939 | Background | 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. |
| 17443559 | Background | 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. |
| 10740794 | Background | 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. |
| 11690728 | Background | 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. |
| 9408716 | Background | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type of wounds | Count of Participants | Participants |
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| Size of wounds | Mean | Standard Deviation | cm |
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| Presence of exudate | Count of Participants | Participants |
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| Odour of wounds | Count of Participants | Participants |
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| Edges of wounds | Count of Participants | Participants |
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| Colour of wounds | Count of Participants | Participants |
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| Wounds classification | Definition of NPUAP Stage 2 Pressure Injury: Partial-thickness skin loss with exposed dermis | Count of Participants | Participants |
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| Concomitant Therapies | Count of Participants | Participants |
|
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| Primary | 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. | The degree of pain intensity was recorded by patients on daily diary and revised by Investigators at final visit. | Posted | Mean | Standard Deviation | Score on a scale | Every day for 15 days |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 15 days, starting from informed consent signature up to the end of the study |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 13 |
| 78 |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| BURNING SENSATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Stomach Ache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| PYODERMA GANGRENOSUM | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| COUGH | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| ACCIDENTAL FALL WITH FACIAL TRAUMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| FEVER | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Wound Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| A lot |
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| Complete relief |
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| NPRS score of Day 3 |
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| NPRS score of Day 15 |
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| 3 adverse events |
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| 4 adverse events |
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| 5 adverse events |
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