• Journal of wound care · Jan 2020

    Randomized Controlled Trial Comparative Study

    Regenerated oxidised cellulose versus calcium alginate in controlling bleeding from malignant breast cancer wounds: randomised control trial study protocol.

    • Flávia Firmino, Juliano Santos, Karina Cardoso Meira, Janille Luciana de Araújo, Valter Alvarenga Júnior, and de Gouveia SantosVera Lúcia ConceiçãoVLCDepartment of Medical-Surgical Nursing, School of Nursing, University of São Paulo, São Paulo, Brazil..
    • School of Nursing of the University São Paulo, São Paulo, Brazil.
    • J Wound Care. 2020 Jan 2; 29 (1): 52-60.

    ObjectiveMalignant wounds due to breast cancer can present with recurrent episodes of bleeding in the tumour tissue. This study will compare the efficacy of a calcium alginate dressing (Biatain, Coloplast A/S, Denmark) and a regenerated oxidised cellulose dressing (Surgicel, Ethicon, LLC, Puerto Rico).ProtocolA total of 24 patients with breast cancer and bleeding, malignant wounds will be enrolled in the randomised, controlled, open study, conducted at a hospital specialising in breast cancer treatment and at another hospital specialising in palliative care. Patients over 18 years old, with bleeding and willing to undergo venipuncture for blood collection will be included. All enrolled patients will be randomised for allocation to an experimental group (regenerated oxidised cellulose dressing) or a control group (calcium alginate dressing). The main intervention will consist of the application of the haemostatic product, assessment of digital pressure and estimation of the time required for haemostasis.OutcomesKey outcome measures will be the percentage of patients with haemostasis within 20 minutes, observation of haemostasis after three, five and 10 minutes, in addition to recurrence of bleeding and the quantity of product used.DiscussionTo our knowledge, this is the first study to evaluate the effectiveness of haemostatic products in malignant wounds. This type of wound is poorly explored in the literature and, among its signs and symptoms, bleeding is poorly studied. The completion of this study will provide a more robust rationale for clinical decision-making related to the control of bleeding in malignant breast cancer wounds in the context of evidence-based nursing practices.

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