Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
NCT ID: NCT03720119
Last Updated: 2023-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
78 participants
OBSERVATIONAL
2015-01-27
2018-03-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SOFAR S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Marco Romanelli, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero, Universitaria Pisana
Elia Ricci, MD
Role: STUDY_CHAIR
Clinica San Luca, Torino
Locations
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Azienda Ospedaliero Pisana
Pisa, , Italy
Ospedali Riuniti Trieste
Trieste, , Italy
Countries
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References
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Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556.
Dallam L, Smyth C, Jackson BS, Krinsky R, O'Dell C, Rooney J, Badillo C, Amella E, Ferrara L, Freeman K. Pressure ulcer pain: assessment and quantification. J Wound Ostomy Continence Nurs. 1995 Sep;22(5):211-5; discussion 217-8. doi: 10.1097/00152192-199509000-00007.
Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
Chase SK, Melloni M, Savage A. A forever healing: the lived experience of venous ulcer disease. J Vasc Nurs. 1997 Jun;15(2):73-8. doi: 10.1016/s1062-0303(97)90004-2.
Briggs M, Closs SJ. Patients' perceptions of the impact of treatments and products on their experience of leg ulcer pain. J Wound Care. 2006 Sep;15(8):333-7. doi: 10.12968/jowc.2006.15.8.26941.
Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004846. doi: 10.1002/14651858.CD004846.pub2.
Santiago S, Ferrer T, Espinosa ML. Neurophysiological studies of thin myelinated (A delta) and unmyelinated (C) fibers: application to peripheral neuropathies. Neurophysiol Clin. 2000 Feb;30(1):27-42. doi: 10.1016/S0987-7053(00)88865-6.
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials. 1997 Dec;18(6):530-45; discussion 546-9. doi: 10.1016/s0197-2456(97)00008-1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SINALGO
Identifier Type: -
Identifier Source: org_study_id
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