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

NCT03720119 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2023-04-12

Study results available
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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.

Conditions

  • Wound Healing Disorder

Interventions

DRUG

Lidocaine Hydrochloride

As per clinical practice, a local treatment with ORTODERMINA® over a 14-day period (once a day) was prescribed. ORTODERMINA® contains 5% of lidocaine hydrochloride.

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Marco Romanelli, MD · Azienda Ospedaliero, Universitaria Pisana

  • Elia Ricci, MD · Clinica San Luca, Torino

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-27
Primary Completion
2018-03-05
Completion
2018-03-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720119 on ClinicalTrials.gov