Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

SOFAR

Status: Completed

Conditions: Wound Healing Disorder

Treatments: Drug: Lidocaine Hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT03720119

SINALGO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design