Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02584335
Eligibility Criteria:
Inclusion Criteria:
* Patient who has accepted and signed the informed consent before the random process.
* Patients with painful wound treatments
* Wounds or sores of any aetiology (vascular insufficiency, diabetics, traumatic, postsurgical...) that implies at minimum dermis or epidermis, it is, II to IV degree in the Spanish Classification of Sores made by the "National Group to Study and Management of Pressure Ulcers and Chronic Wounds" (GNEAUPP).
* Women in fertile age with pregnancy test negative.
* Men and women in fertile age using contraceptive measures
Exclusion Criteria:
* Precedents of allergic reaction to local anesthesics type amides.
* Wounds or sores degree I on the GNEAUPP Classification (without discontinuity of skin).
* Wounds or sores too large (which require more than 40 ml of solution to cover).
* Wounds around the eyes.
* Patients who presents disturbance of cardiac conduction: atrioventricular block (second or third degree) or bifascicular block
* Patients with altered level of consciousness (Glasgow Coma Scale value less than 14)
* Patients following hemodialysis, peritoneal dialysis or continuous hemofiltration treatment.
* Patients suffering moderate or severe hepatic insufficiency.
* Pregnant or lactating women.
* Patients who refuse to participate in the study.
* Patients requiring wounds treatment more than once each day.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02584335
Study Brief:
Protocol Section:
NCT02584335