Wound Healing Disorder
Conditions
Keywords
wound healing, pain, lidocaine
Brief summary
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
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.
Interventions
DRUGLidocaine 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.
Sponsors
SOFAR S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Every day for 15 days | 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. |
| Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 15 days, starting from informed consent signature up to the end of the study | Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study |
Countries
Italy
Participant flow
Recruitment details
Patients were recruited from January 27, 2015 to March 05, 2018 in three Italian hospitals in Pisa and Trieste
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | Single Cohort |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 21.4 |
| Colour of wounds Not defined | 10 Participants |
| Colour of wounds Pink/red/yellow | 68 Participants |
| Concomitant Therapies 1 therapy | 19 Participants |
| Concomitant Therapies 2-4 therapies | 25 Participants |
| Concomitant Therapies >4 therapies | 6 Participants |
| Concomitant Therapies No therapy | 28 Participants |
| Edges of wounds Herythematous | 6 Participants |
| Edges of wounds Irregular | 18 Participants |
| Edges of wounds Not defined | 3 Participants |
| Edges of wounds Reactive | 11 Participants |
| Edges of wounds Regular | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Odour of wounds Absent | 78 Participants |
| Odour of wounds Present | 0 Participants |
| Presence of exudate Not defined | 2 Participants |
| Presence of exudate Not present | 23 Participants |
| Presence of exudate Present | 53 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 29 Participants |
| Size of wounds Depth | 0.29 cm STANDARD_DEVIATION 0.29 |
| Size of wounds Length | 4.76 cm STANDARD_DEVIATION 3.35 |
| Size of wounds Width | 5.99 cm STANDARD_DEVIATION 5.13 |
| Type of wounds Geriatric | 1 Participants |
| Type of wounds Pathological | 31 Participants |
| Type of wounds Surgical | 7 Participants |
| Type of wounds Traumatic | 39 Participants |
| Wounds classification Not available | 18 Participants |
| Wounds classification NPUAP Grade II | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 13 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
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.
Time frame: Every day for 15 days
Population: The degree of pain intensity was recorded by patients on daily diary and revised by Investigators at final visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 1 | 6.7 Score on a scale | Standard Deviation 1.9 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 2 | 5.4 Score on a scale | Standard Deviation 1.91 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 3 | 5.0 Score on a scale | Standard Deviation 2.09 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 4 | 4.7 Score on a scale | Standard Deviation 2.17 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 5 | 4.1 Score on a scale | Standard Deviation 2.16 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 6 | 3.9 Score on a scale | Standard Deviation 2.2 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 7 | 3.6 Score on a scale | Standard Deviation 2.05 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 8 | 3.6 Score on a scale | Standard Deviation 2.22 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 9 | 3.6 Score on a scale | Standard Deviation 2.22 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 10 | 3.4 Score on a scale | Standard Deviation 2.28 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 11 | 3.2 Score on a scale | Standard Deviation 2.4 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 12 | 3.2 Score on a scale | Standard Deviation 2.4 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 13 | 3.3 Score on a scale | Standard Deviation 2.48 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 14 | 3.0 Score on a scale | Standard Deviation 2.27 |
| Single Cohort | Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) | NPRS score of Day 15 | 2.8 Score on a scale | Standard Deviation 2.23 |
p-value: 0.0001Dunnett's post-hoc test
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.
Time frame: Every day for 15 days
Population: There are missing data in some time-points
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 4 | Moderate | 31 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 4 | A lot | 15 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 4 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 5 | None relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 5 | Mild | 17 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 5 | Moderate | 39 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 5 | A lot | 11 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 5 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 6 | None relief | 6 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 6 | Mild | 21 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 6 | Moderate | 33 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 6 | A lot | 9 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 6 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 7 | None relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 7 | Mild | 16 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 7 | Moderate | 35 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 7 | A lot | 9 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 7 | Complete relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 8 | None relief | 7 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 8 | Mild | 18 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 8 | Moderate | 25 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 8 | A lot | 15 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 8 | Complete relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 9 | None relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 9 | Mild | 22 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 9 | Moderate | 22 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 9 | A lot | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 9 | Complete relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 10 | None relief | 10 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 10 | Mild | 16 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 10 | Moderate | 22 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 10 | A lot | 16 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 10 | Complete relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 11 | None relief | 10 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 11 | Mild | 16 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 11 | Moderate | 20 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 11 | A lot | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 11 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 12 | None relief | 12 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 12 | Mild | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 12 | Moderate | 20 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 12 | A lot | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 12 | Complete relief | 5 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 13 | None relief | 16 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 13 | Mild | 10 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 13 | Moderate | 20 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 13 | A lot | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 13 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 14 | None relief | 14 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 14 | Mild | 11 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 14 | Moderate | 20 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 14 | A lot | 12 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 14 | Complete relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 15 | None relief | 13 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 15 | Mild | 13 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 15 | Moderate | 15 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 15 | A lot | 13 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 15 | Complete relief | 4 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 2 | None relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 2 | Mild | 23 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 2 | Moderate | 28 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 2 | A lot | 20 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 2 | Complete relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 3 | None relief | 2 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 3 | Mild | 24 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 3 | Moderate | 30 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 3 | A lot | 18 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 3 | Complete relief | 2 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 4 | None relief | 3 Participants |
| Single Cohort | Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) | Day 4 | Mild | 24 Participants |
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
Time frame: 15 days, starting from informed consent signature up to the end of the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 3 adverse events | 2 Participants |
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 0 adverse event | 65 Participants |
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 1 adverse event | 8 Participants |
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 2 adverse events | 1 Participants |
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 4 adverse events | 1 Participants |
| Single Cohort | Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 5 adverse events | 1 Participants |