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

Objective: Malignant 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).
Protocol: A 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.
Outcomes: Key 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.
Discussion: To 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.