N/A
N=78
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Wound Healing Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03720119 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) — 3; 23; 28; 20 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lidocaine Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SOFAR S.p.A.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) |
3; 23; 28; 20; 3; 2 | — |
| PRIMARY Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) |
6.7; 5.4; 5.0; 4.7; 4.1; 3.9 | 0.0001 sig |
| SECONDARY Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
65; 8; 1; 2; 1; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03720119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.