Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborator: Newco Trials Pesquisa Científica Ltda
• Treatments: Chorionic Gonadotropin

Criteria

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.