Abstract
BackgroundEssential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. Before testing the effectiveness of heat preconditioning in a definitive randomised controlled trial (RCT), we must first establish the best way to measure skin necrosis and estimate the event rate using this definition.MethodsPREHEAT is a single-blind randomised controlled feasibility trial comparing local heat preconditioning, using a hot water bottle, against standard care on skin necrosis among breast cancer patients undergoing reconstructive breast surgery. The primary objective of this study is to determine the best way to measure skin necrosis and to estimate the event rate using this definition in each trial arm. Secondary feasibility objectives include estimating recruitment and 30 day follow-up retention rates, levels of compliance with the heating protocol, length of stay in hospital and the rates of surgical versus conservative management of skin necrosis. The information from these objectives will inform the design of a larger definitive effectiveness and cost-effectiveness RCT.DiscussionThis article describes the PREHEAT trial protocol and detailed statistical analysis plan, which includes the pre-specified criteria and process for establishing the best way to measure necrosis. This study will provide the evidence needed to establish the best way to measure skin necrosis, to use as the primary outcome in a future RCT to definitively test the effectiveness of local heat preconditioning. The pre-specified statistical analysis plan, developed prior to unblinded data extraction, sets out the analysis strategy and a comparative framework to support a committee evaluation of skin necrosis measurements. It will increase the transparency of the data analysis for the PREHEAT trial.Trial registrationISRCTN ISRCTN15744669. Registered 25 February 2015
Highlights
Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery
There is evidence that heat preconditioning could help improve the provision of skin-sparing mastectomy at minimal cost by reducing the occurrence of skin necrosis
PREHEAT is a randomised controlled feasibility study for a trial that will evaluate the effectiveness of local heat preconditioning with respect to its effects on wound healing after reconstructive breast surgery in patients with breast cancer
Summary
Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. There are essentially two types of reconstruction that a patient can have after mastectomy: implant-based or autologous flaps, where the patient’s own tissue is used to create a new breast. Skin-sparing mastectomy (SSM) followed by autologous microsurgical breast reconstruction is an increasingly popular procedure within the UK [3]. It results in highly satisfactory results both oncologically and cosmetically from a surgical and patient’s perspective [4]. In 2011, 16,485 women underwent mastectomy in the UK and approximately a third of these underwent autologous reconstruction [5]
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