Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03720119
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2018-10-15
Brief Title:
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA
Sponsor:
SOFAR SpA
Organization:
SOFAR SpA
Study Overview
Official Title:
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None