Clinical trial NCT03720119: Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Official title: Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Healing Disorder
Keywords: wound healing
pain
lidocaine
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
timeFrame: Every day for 15 days
measure: Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
timeFrame: Every day for 15 days
Secondary outcomes:
measure: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 15 days, starting from informed consent signature up to the end of the study
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero Pisana
city: Trieste
country: Italy
facility: Ospedali Riuniti Trieste
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Marco Romanelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica San Luca, Torino
name: Elia Ricci, MD
role: STUDY_CHAIR
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