Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers. (NCT02004626) | Clinical Trial Compass
WithdrawnPhase 3
Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.
Brazil0Started 2015-01
Plain-language summary
This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority.
Its purpose is to determine the noninferiority in efficacy of an investigational product in relation to the product available in the market intended of treating pressure ulcers.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Both sexes;
* Aged ≥ 18 years and ≤ 80 years;
* Patients hospitalized;
* Patients with leg ulcers in the sacral region with presence of devitalized/ necrotic tissue indicating conservative debridement;
* Understanding, agreement and signing the Informed Consent Form (IFC), and the Authorization Term for the Image Use for publication of results
Exclusion Criteria:
* Infected ulcers;
* Limited ulcers;
* Ulcers with indication for surgical debridement ;
* Periostitis ;
* Obesity II( BMI ≥ 35 ) ;
* Severe malnutrition ( BMI \< 16 )
* Hemoglobin (HbA1c ) above the upper limit of normal (ULN ) ;
* Coagulation Factor twice the ULN ;
* Patients with pulmonary emphysema and / or Chronic Obstructive Pulmonary Disease (COPD) ;
* Collagen diseases;
* Psychiatric illnesses;
* Patients using cytotoxic agents ;
* Oncology patients under palliative care ;
* Outpatients ;
* Signs of limb ischemia ;
* Urinary incontinence uncontrolled;
* Fecal incontinence;
* Diarrhea that in the opinion of the investigator , compromise the process of debridement;
* Known allergy from the components of the formulas;
* Pregnancy ;
* Breastfeeding ;
* Local and concomitant use of medications and / or products in the lesion: tyrothricin , gramicidin , tetracycline , hexachlorophene , heavy metals ( mercury, silver) , iodine , potassium permanganate , hydrogen peroxide , soap, detergent.