Varicose ulcers
Conditions
Interventions
There will be two randomized groups, with 35 participants in each group:
Group 1: subjects with venous ulcers treated with biomembrane hemicellulose dressing with change once a day associated with com
Other
Sponsors
Faculdade de Medicina de Botucatu - Unesp
Faculdade de Medicina de Botucatu - Unesp
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the consent form; ge above 18 years; of both sexes; Venous chronic disease with venous chronic ulcer evidenced by one or more of the following signs: Hyperpigmentation of the distal third of the lower limb; stasis eczema; lipodermatosclerosis; varicose veins; One or more ulcers whose minimum evolution time is 6 weeks; present ulcer whose largest size is linear up to 20cm; Ulcers do not occur throughout the circumference of the member Do not use venotonics drugs; pentoxifylline and fibrinolytic drugs in the last two weeks before the study
Exclusion criteria
Exclusion criteria: Having other etiologies ulcers (peripheral arterial disease, causes hematologic, neoplastic, infectious, etc.); Ulcer whose largest linear size is more than 20cm; Ulcers occurring throughout the limb circumference; Infected ulcer, or when combined with erysipelas, cellulitis or lymphangitis; Ulcers with critical colonization, or large amounts of exudate and/or foul odor and/or color of the green bed; Necrosis presence in ulcer bed; Venous ulcers associated with peripheral arterial disease that is characterized when the ankle-brachial systolic index (ABI) is less than 0.9 and / or absence of distal pulses, mainly tibioso; History of hypersensitivity to the proposed treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in ulcer area during the 90 day treatment period: it will be calculated by the average ulcerated area before the initiation of treatment (T0), the 30th day after start of treatment (T30), day 60 (T60 ) and day 90 (T90). For the measurement of the area, each ulcer will be analyzed using the planimetric method using drawing the outlines in clear plastic film. Later it will be captured digital photos directly from these images. To create a frame of photographic measurements, the drawings will be photographed and placed a known size adhesive adjacent the edge of the design. From known external reference, establish the length of the relationship (pixels/mm) individualized for each picture and the computer to perform the manual tracing the perimeter of ulcers and will be calculated in your area pixel, and then transformed into cm2. Captured images will be analyzed using the ImageJ 1.37v software; There was a reduction of the area as a function of time, with no difference between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete healing: defined as having a "wound closed ', i.e., complete re-epithelization of the wound with no drain. This outcome will be assessed by the researcher in patient assessment;Of the 73 ulcers healed 19, 12 of the biomembrane group and 7 in the collagenase group. There was no statistically significant difference between groups (p=0.206);Reduction or absence of devitalized tissue in the ulcer bed: this analysis will be performed at T0, T30 and T90. All ulcers will be photographed for the evaluation will be performed by two methods: 1- by researcher in clinical care; 2 by two external examiners through the photographic images captured at the time of service. In the latter case, the examiners will not be aware of the group the patient belongs and have standardized worksheet for recording the information;This outcome was analyzed by two external evaluators to study without knowledge of the groups that were ulcers . Data on photographic analysis according to the evaluators 1 and 2, distributed by study group at 0, 30 and 90 and conducted longitudinal analysis. There was improvement in the vitality of the bed for both groups as a function of time, but no statistical difference between the groups. According to researcher's analysis of the vitality of the ulcer bed for study group. negative binomial distribution was carried out , and also in real-time evaluation of the researcher profile modification was a function of time , with no differences between groups (p=0,26) ;exudate reduction: will be evaluated by the researcher at the time of clinical care at T0, T30 and T90, the amount of exudate may be absent, small, medium and large;This outcome was analyzed by the researcher in T0 visits, T30 , T60 and T90 . negative binomial distribution was carried out on this analysis , there was no variation in the amount of exudate in accordance with time or with treatment ;Local adverse events: pain , ulcer edge maceration, eczema, local infection (erysipelas, cellulitis, l | — |
Countries
Brazil
Contacts
Public Contactraquel colenci
Departamento de Enfermagem
Outcome results
None listed