Efficacy of oxidized regenerated celulose versus calcium alginate in the control of bleeding from malignant wounds in breast cancer: a Randomized Clincal Trial

INTRODUCTION: Malignant wounds (MW) present bleeding due to tumor angiogenesis or the rupture of adjacent blood vessels. Topical hemostasis is recommended by expert opinion. Regenerated oxidized cellulose (ROC) and alginate calcium (AC) are indicated for surgical hemostasis and there is no robust evidence for its use in the control of MW bleeding. OVERALL OBJECTIVE: To evaluate the efficacy of ROC versus AC in the control of bleeding in malignant wounds due to breast cancer. METHOD: A randomized, stratified, parallel, controlled, open, unicentric clinical trial was conducted from October 2017 to August 2018, recruiting patients at the National Cancer Institute INCA. We selected 13 women for the control group and 15 for the ROC group, with bleeding MW due to breast cancer, aged 18 years or older. The main exclusion criteria were: presence of arterial bleeding or contraindication to topical hemostasis, hematological comorbidities and previous participation in the same study. The main dependent variables were: hemostasis, total time for hemostasis (TTH), rebleeding and amount of hemostatic products used. The main independent variables were: number of platelets, coagulogram, and tumor, MW and bleeding staging. The hypothesis stated that there was an average difference of five minutes in the use of ROC compared to the standard dressing. The intervention consisted of random (using opaque envelopes) administration of the products and TTH counting, preceded by blood collection, vital signs measurement and evaluation of the wound and bleeding. The primary endpoint was TTH; secondary endpoints were: proportion of women who achieved hemostasis before 20 minutes, hemostasis at three, five and 10 minutes, rebleeding and amount of hemostatic dressings used. Descriptive statistics were applied for nominal and ordinal variables, by means of absolute frequencies; for the continuous ones: mean and standard deviation. The endpoints were evaluated using the Cox risk model, Kaplan Meier curve and Long-rank test for the TTH. The study was approved by the Research Ethics Committees of INCA (Opinion number: 2.2286.120) and the School of Nursing of the University of São Paulo EEUSP (Opinion number: 2.286.120). RESULTS: TTH was median of 30.4 (95% CI: 21.7 imprecise upper limit) in the AC group and median of 30.1 (95% CI: 18.6 189) in the ROC group. The mean difference between the groups was 0.5 minutes, with no statistical significance (p = 0.897). At 3 minutes, 92% (12/13) patients in the AC group and 85% (12/14) of the ROC group had reached hemostasis. From In the 5 minute the result remained and from minutes 10, 100% (13/13) achieved haemostasis in the AC group and 93% (13/15) in the ROC group. There were two rebleedings in the ROC group. EIghteen hemostatic dressings were used in the control group and 34 in the ROC group. There were no damages/adverse effects. CONCLUSIONS: There was no evidence of a difference in hemostatic efficacy between groups. Further studies with larger samples are suggested.