Efficacy of Regenerated Oxidized Cellulose versus Calcium Alginate in Bleeding from Breast Wounds caused by Cancer

Not Applicable

Recruiting

• Conditions: Breast Neoplasms; Wounds and Injuries; C04.588.180

• Registration Number: RBR-9mqzvz
• Lead Sponsor: Escola de Enfermagem da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.