Randomized, double-blind intervention study of efficacy and safety of the product Vioplex-T compared with placebo in patients with open sores (pressure ulcers).

INTERVENTION: Trade Name: Vioplex‐ T Product Name: Vioplex‐T Product Code: 1949801 Pharmaceutical Form: Cutaneous spray, powder Pharmaceutical form of the placebo: Cutaneous spray, powder Route of administration of the placebo: Cutaneous use CONDITION: Pressured Ulcers in I & II Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: Evaluate the efficacy of topical treatment with VIOPLEX‐T in the healing of pressure ulcers stage II and III after 4 weeks of application of it Primary end point(s): The primary efficacy variable is the difference between the group of study drug and the placebo group with regard to the degree of healing of pressure ulcers after 4 weeks of treatment. The healing of pressure ulcers assessed the scale PUSH Secondary Objective: The evaluation of local therapy VIOPLEX‐T in reducing the microbial load in bedsores stage II and III Timepoint(s) of evaluation of this end point: 4 weeks SECONDARY OUTCOME: Secondary end point(s): • The time course, within 4 weeks of price reduction scale PUSH for both teams. ; • The evaluation of topical treatment with the investigational drug in reducing the microbial load in pressure ulcers stage II and III ; • The assessment of the safety of topical treatment with the investigational drug. Timepoint(s) of evaluation of this end point: The time course of the cumulative reduction in value of the scale PUSH and the difference between the two groups especially in the second week. ; • We will evaluate the difference between the group of study drug and placebo with regard to the extent of healing pressure ulcers every week measurement. ; • The time until reduction in scale PUSH least two points below the original estimate. ; • The time course of the cumulative reduction of microbial load in samples of liquid cultures of pressure ulcers and the difference between the two groups especially in the 2nd and 4th week. ; • will evaluate the difference in the reduction of the microbial load in cultures of samples of fluid pressure ulcers between the two groups in each week measurement. INCLUSION CRITERIA: Patients with 1 to 3 pressure ulcers stage II and / or III. pressure ulcers being evaluated should have occurred at least 4 weeks prior to study initiation. In cases of patients who have more than one pressure ulcers but = 3, the pressure ulcer that will be selected for evaluation of treatment, from the investigator, is the one that needs the most time of healing. • Patient Age:> 18 years • Gender: Women ‐ Men • Body Mass Index (BMI): = 30 kg/m2. Defined as the ratio of weight (in kilograms) by the square of height (in meters). For a definition of these limits are taken into account, the tables in World Health Organization (WHO). • Written consent from the patients for their participation in the study. • Negative pregnancy test for women of childbearing age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 101 F.1.3 Elderly (>=65