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

Wound Healing Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03720119
Study type Observational
Source SOFAR S.p.A.
Contact
Status Completed
Phase
Start date January 27, 2015
Completion date March 5, 2018
View Details
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