An observational study in Wound Healing Disorder, sponsored by SOFAR S.p.A.. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by SOFAR S.p.A. · Observational
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: ORTODERMINA®
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.
Time frame: 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.
Time frame: Every day for 15 days
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
Time frame: 15 days, starting from informed consent signature up to the end of the study
Patients were recruited from January 27, 2015 to March 05, 2018 in three Italian hospitals in Pisa and Trieste
| Milestone | Single Cohort |
|---|---|
| Started | 78 |
| Completed | 69 |
| Not completed | 9 |
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.
| Participants | Single Cohort |
|---|---|
| Day 2 — None relief | 3 |
| Day 2 — Mild | 23 |
| Day 2 — Moderate | 28 |
| Day 2 — A lot | 20 |
| Day 2 — Complete relief | 3 |
| Day 3 — None relief | 2 |
| Day 3 — Mild | 24 |
| Day 3 — Moderate | 30 |
| Day 3 — A lot | 18 |
| Day 3 — Complete relief | 2 |
| Day 4 — None relief | 3 |
| Day 4 — Mild | 24 |
| Day 4 — Moderate | 31 |
| Day 4 — A lot | 15 |
| Day 4 — Complete relief | 4 |
| Day 5 — None relief | 5 |
| Day 5 — Mild | 17 |
| Day 5 — Moderate | 39 |
| Day 5 — A lot | 11 |
| Day 5 — Complete relief | 4 |
| Day 6 — None relief | 6 |
| Day 6 — Mild | 21 |
| Day 6 — Moderate | 33 |
| Day 6 — A lot | 9 |
| Day 6 — Complete relief | 4 |
| Day 7 — None relief | 5 |
| Day 7 — Mild | 16 |
| Day 7 — Moderate | 35 |
| Day 7 — A lot | 9 |
| Day 7 — Complete relief | 5 |
| Day 8 — None relief | 7 |
| Day 8 — Mild | 18 |
| Day 8 — Moderate | 25 |
| Day 8 — A lot | 15 |
| Day 8 — Complete relief | 5 |
| Day 9 — None relief | 5 |
| Day 9 — Mild | 22 |
| Day 9 — Moderate | 22 |
| Day 9 — A lot | 14 |
| Day 9 — Complete relief | 3 |
| Day 10 — None relief | 10 |
| Day 10 — Mild | 16 |
| Day 10 — Moderate | 22 |
| Day 10 — A lot | 16 |
| Day 10 — Complete relief | 3 |
| Day 11 — None relief | 10 |
| Day 11 — Mild | 16 |
| Day 11 — Moderate | 20 |
| Day 11 — A lot | 14 |
| Day 11 — Complete relief | 4 |
| Day 12 — None relief | 12 |
| Day 12 — Mild | 14 |
| Day 12 — Moderate | 20 |
| Day 12 — A lot | 14 |
| Day 12 — Complete relief | 5 |
| Day 13 — None relief | 16 |
| Day 13 — Mild | 10 |
| Day 13 — Moderate | 20 |
| Day 13 — A lot | 14 |
| Day 13 — Complete relief | 4 |
| Day 14 — None relief | 14 |
| Day 14 — Mild | 11 |
| Day 14 — Moderate | 20 |
| Day 14 — A lot | 12 |
| Day 14 — Complete relief | 3 |
| Day 15 — None relief | 13 |
| Day 15 — Mild | 13 |
| Day 15 — Moderate | 15 |
| Day 15 — A lot | 13 |
| Day 15 — Complete relief | 4 |
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.
| Score on a scale | Single Cohort |
|---|---|
| NPRS score of Day 1 | 6.7 ± 1.90 |
| NPRS score of Day 2 | 5.4 ± 1.91 |
| NPRS score of Day 3 | 5.0 ± 2.09 |
| NPRS score of Day 4 | 4.7 ± 2.17 |
| NPRS score of Day 5 | 4.1 ± 2.16 |
| NPRS score of Day 6 | 3.9 ± 2.2 |
| NPRS score of Day 7 | 3.6 ± 2.05 |
| NPRS score of Day 8 | 3.6 ± 2.22 |
| NPRS score of Day 9 | 3.6 ± 2.22 |
| NPRS score of Day 10 | 3.4 ± 2.28 |
| NPRS score of Day 11 | 3.2 ± 2.40 |
| NPRS score of Day 12 | 3.2 ± 2.40 |
| NPRS score of Day 13 | 3.3 ± 2.48 |
| NPRS score of Day 14 | 3.0 ± 2.27 |
| NPRS score of Day 15 | 2.8 ± 2.23 |
Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study
| Participants | Single Cohort |
|---|---|
| 0 adverse event | 65 |
| 1 adverse event | 8 |
| 2 adverse events | 1 |
| 3 adverse events | 2 |
| 4 adverse events | 1 |
| 5 adverse events | 1 |
Collected over 15 days, from informed consent signature to the end of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Cohort | 0/78 (0%) | 0/78 (0%) | 13/78 (16.7%) |
| Event | Single Cohort |
|---|---|
| PainMusculoskeletal and connective tissue disorders | 3/78 |
| InfectionInfections and infestations | 3/78 |
| PainGeneral disorders | 3/78 |
| BURNING SENSATIONInjury, poisoning and procedural complications | 1/78 |
| Stomach AcheGastrointestinal disorders | 1/78 |
| PYODERMA GANGRENOSUMInfections and infestations | 1/78 |
| COUGHInfections and infestations | 1/78 |
| ACCIDENTAL FALL WITH FACIAL TRAUMAInjury, poisoning and procedural complications | 1/78 |
| FEVERGeneral disorders | 1/78 |
| HeartburnGastrointestinal disorders | 1/78 |
| Age, Continuous(years) | Single Cohort |
|---|---|
| Mean | 62.4 ± 21.4 |
| Sex: Female, Male(Participants) | Single Cohort |
|---|---|
| Female | 49 |
| Male | 29 |
| Ethnicity (NIH/OMB)(Participants) | Single Cohort |
|---|---|
| Hispanic or Latino | 78 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Type of wounds(Participants) | Single Cohort |
|---|---|
| Traumatic | 39 |
| Pathological | 31 |
| Surgical | 7 |
| Geriatric | 1 |
| Size of wounds(cm) | Single Cohort |
|---|---|
| Width | 5.99 ± 5.13 |
| Length | 4.76 ± 3.35 |
| Depth | 0.29 ± 0.29 |
| Presence of exudate(Participants) | Single Cohort |
|---|---|
| Present | 53 |
| Not present | 23 |
| Not defined | 2 |
| Odour of wounds(Participants) | Single Cohort |
|---|---|
| Absent | 78 |
| Present | 0 |
| Edges of wounds(Participants) | Single Cohort |
|---|---|
| Regular | 40 |
| Irregular | 18 |
| Reactive | 11 |
| Herythematous | 6 |
| Not defined | 3 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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SOFAR S.p.A.