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

Saahil Mehta,Rachel Rolph,Billie Coomber,Jian Farhadi,Victoria Cornelius,Suzie Cro Cro

doi:10.1186/s40814-019-0392-y

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: 25/02/2018

Highlights

Mastectomy skin flap necrosis (MSFN) is a serious complication resulting in prolonged wound healing
17% (n = 4/23) patients experiencing necrosis required surgical intervention for necrosis compared to 11% (n = 2/18) in the heated group
sparing mastectomy (SSM) and nipple sparing mastectomy (NSM) with reconstruction are already costly procedures reducing the incidence of skin necrosis to improve patient recovery and to reduce the financial burden to the NHS is of high interest

Summary

Introduction

Mastectomy skin flap necrosis (MSFN) is a serious complication resulting in prolonged wound healing. According to the most recent NICE guidance, immediate breast reconstruction should be available to all women requiring a mastectomy for breast cancer in the UK [1]. Due to the delicate blood supply to the skin of the mastectomy skin flap, it is often susceptible to mastectomy skin flap necrosis (MSFN). This can require further surgical interventions, delayed recovery and an increased length of stay (LOS) in hospital, which can cause a delay in the delivery of adjuvant cancer treatment and compromise oncological outcomes. SSM and NSM with reconstruction are already costly procedures reducing the incidence of skin necrosis to improve patient recovery and to reduce the financial burden to the NHS is of high interest

Methods

Results

Discussion

Conclusion