Breast Neoplasms
Conditions
Interventions
The interventions being tested and compared are hemostasis in wounds arising from breast cancer through the application of hemostatic based on regenerated oxidized cellulose and based on calcium algin
Device
Procedure/surgery
D27.505.954.502.270.463
Sponsors
Escola de Enfermagem da Universidade de São Paulo
Hospital de Câncer III do Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Hospital de Câncer IV do Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be 18 or older; have breast cancer with hemorrhagic wound in one or both breasts; being in stable emotional conditions that allow participation in the intervention of the study; and accept venipuncture for blood collection.
Exclusion criteria
Exclusion criteria: Patients who have bleeding present in the malignant wound of the breast due to arterial cause; bleeding present in the malignant wound of the breast but without visualization of the origin of the bleeding site; patients with a known allergy to the hemostatic products used in the main study intervention, and patients who have had bleeding in their malignant breast wounds, but who have already participated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: proportion of the number of participants who reached hemostasis in the 20-minute time-out period, measured after randomization, verified by counting the application time and digital compression by stopwatch considering a variation of up to 5% in the measurements.;Expected outcome 2: proportion of the number of participants who did not achieve hemostasis in the 20-minute time-out period, measured after randomization, verified by means of counting of the application time and digital compression by stopwatch considering a variation of up to 5% in the measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: total number of patients who achieved hemostasis within the times: three, five and ten minutes, verified through the identification and classification of the time spent in the hemostasis of each participant.;Expected outcome 2: identification of recurrence of bleeding (rebleeding) occurred in the first five minutes after the application of hemostatic intervention, verified through direct visual inspection, having as parameter the absence of blood passing through the hemostatic cover applied.;Expected outcome 3: percentage of bleeding recurrence, verified by means of direct inspection on the secondary coverage of the finished dressing, having as a parameter the presence of blood in the period between the closure of the dressing and the evaluation of the results of the blood tests by the medical team .;Expected outcome 4: survey of the amount of coverage used to obtain hemostasis, using the number of open packs as a parameter, obtained through direct counting at the end of each intervention. | — |
Countries
Brazil
Contacts
Public ContactFlavia Firmino
Universidade de São Paulo
Outcome results
None listed