A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial

Abstract

ObjectivepreHEAT was a randomised controlled feasibility trial to determine how best to measure skin necrosis in breast reconstruction to inform the design of a larger multicentre trial.BackgroundMastectomy skin flap necrosis (MSFN) is a serious complication resulting in prolonged wound healing. Local heat preconditioning of the MSF before surgery has been shown to reduce skin necrosis in immediate breast reconstruction patients (IBR).MethodpreHEAT was a single-centre, randomised control two-arm single-blind parallel arm feasibility trial of local heat preconditioning in breast cancer patients undergoing SSM and NSM at Guy’s and St Thomas’ Hospital, London, UK. All patients undergoing IBR above the age of 18 were included. Intervention patients heated breast skin to 43 °C in three, 30-min cycles interrupted by spontaneous cooling using hot water bottles. The primary aim was to compare measurement of skin necrosis using binary ‘yes/no’ assessment, the SKIN score, and wound area.ResultsOne hundred forty-one patients were randomised over a 2-year period (71 heated group, 70 controls). There was near perfect agreement between assessors using the “yes/no” measurement of necrosis. The proportion of patients experiencing necrosis in controls was 35% (n = 23/66) in the heated 26% (n = 18/68]). In the control group, 17% (n = 4/23) patients experiencing necrosis required surgical intervention for necrosis compared to 11% (n = 2/18) in the heated group.ConclusionThe binary outcome of MSFN “yes/no” is a suitable and reliable primary outcome measure of necrosis and was superior to the SKIN Score or necrosis area. The trial study design is feasible for a larger definitive trial.Trial registrationISRCTN15744669. Date of registration: 25/02/2018Electronic supplementary materialThe online version of this article (10.1186/s40814-019-0392-y) contains supplementary material, which is available to authorized users.

Heat Preconditioning Protects Skin Pressure Injury and Reduces Incidence of Intraoperatively Acquired Pressure Ulcers in Both Humans and Animals

“…Several studies have con rmed that local heating of the skin can signi cantly improve tissue survival. 24,25 The protective effects observed in these studies are thought to be due to the upregulation of HSP70 and HSP32 expression induced by high temperatures. In addition, Mehta et al 11 heated the skin of breast cancer patients in skin-sparing mastectomy and found that HPC could reduce skin necrosis and duration of hospital stay.…”

Implant-Based Breast Reconstruction after Mastectomy, from the Subpectoral to the Prepectoral Approach: An Evidence-Based Change of Mind?

“…Other technical advances have contributed to the trend towards prepectoral IBBR in smaller, yet interesting ways. Several techniques have been described to increase the survival rate and tissue quality of mastectomy flaps; for instance, there is the use of local heat preconditioning [ 92 , 93 ] or hyperbaric oxygen therapy [ 94 ]. Furthermore, the development and clinical implication of intraoperative indocyanine green angiography (ICG) for the real time visualization of tissue perfusion has been another crucial step toward perfecting prepectoral IBBR [ 95 ].…”

Wounds Research Network (WReN) - a community of practice for improving wound care-related trials

“…A critical mass of researchers, academics clinicians, and patients in the UK have undertaken a wide range of innovative trials in pressure ulcers, 26,27 leg ulcers, [28][29][30] burns, 31 and other types of wounds. [32][33][34][35][36][37] The Tissue Viability Society created the WReN (https://woundsrn.org/) in 2015 to provide an interprofessional cross-speciality forum where people may share their knowledge, expertise, and insights regarding wound trials and research. The WReN offers opportunities to people from diverse backgrounds to further develop their knowledge and expertise in conducting high-quality wound trials and research regardless of their levels of expertise.…”