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 Details — Status: Completed

Administrative data

• NCT number: NCT03720119
• Other study ID #: SINALGO
• Status: Completed
• Start date: January 27, 2015
• Est. completion date: March 5, 2018

Study information

• Verified date: October 2019
• Source: SOFAR S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing Disorder
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Pisana	Pisa
Italy	Ospedali Riuniti Trieste	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)	The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief).; Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0.	Every day for 15 days
Primary	Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)	The evaluation of the pain intensity was based on a 11-point Numerical Pain Rating Scale (NPRS score from 0= no pain to 10= the most intense pain imaginable). Patients recorded the NPRS score every day of treatment in their diary.; The improvement in the pain intensity is defined as a decrease in NPRS scores from baseline to the end of treatment.	Every day for 15 days
Secondary	Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study	15 days, starting from informed consent signature up to the end of the study