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

• ClinicalTrials.gov Identifier: NCT03720119
• Recruitment Status: Completed
• First Posted: October 25, 2018
• Results First Posted: November 7, 2019
• Last Update Posted: November 7, 2019
• Sponsor: SOFAR S.p.A.
• Information provided by (Responsible Party): SOFAR S.p.A.

Study Description

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.

Condition or disease	Intervention/treatment
Wound Healing Disorder	Drug: Lidocaine Hydrochloride

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 78 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
• Actual Study Start Date: January 27, 2015
• Actual Primary Completion Date: March 5, 2018
• Actual Study Completion Date: March 5, 2018

Groups and Cohorts

Intervention Details:

• 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.
  Other Name: ORTODERMINA®

Outcome Measures

Primary Outcome Measures :

1. Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) [ Time Frame: Every day for 15 days ]

   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.

2. Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS) [ Time Frame: Every day for 15 days ]

   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.

Secondary Outcome Measures :

1. Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 15 days, starting from informed consent signature up to the end of the study ]
   Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

A sample size of 70 evaluable patients is needed to test the hypothesis of an improvement in wound pain relief and a reduction in pain intensity, assuming a standardized effect size equal to 0.35, for a one-tailed test with a 5% significance level and a 90% power. A 10% of attrition rate is expected; therefore, a total number of patients to be enrolled is 78.

Criteria

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

Contacts and Locations

Locations

Italy

Azienda Ospedaliero Pisana

Pisa, Italy

Ospedali Riuniti Trieste

Trieste, Italy

Sponsors and Collaborators

SOFAR S.p.A.

Investigators

• Principal Investigator: Marco Romanelli, MD; Azienda Ospedaliero, Universitaria Pisana
• Study Chair: Elia Ricci, MD; Clinica San Luca, Torino

  Study Documents (Full-Text)

Documents provided by SOFAR S.p.A.:

Study Protocol and Statistical Analysis Plan  [PDF] October 23, 2015

More Information

Publications:

Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. Review.

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.

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.

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.

Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004846. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004846.

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. Review.

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. Review.

• Responsible Party: SOFAR S.p.A.
• ClinicalTrials.gov Identifier: NCT03720119
• Other Study ID Numbers: SINALGO
• First Posted: October 25, 2018
• Results First Posted: November 7, 2019
• Last Update Posted: November 7, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SOFAR S.p.A.:

wound healing; pain; lidocaine

Additional relevant MeSH terms:

Wounds and Injuries; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action