Title: A feasibility study to evaluate local heat preconditioning with respect to its effects on wound healing after reconstructive breast surgery in patients with breast cancer– a single blind randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Skin sparing mastectomy followed by autologous microsurgical breast reconstruction is an increasingly popular procedure within the UK (6). According to the National Mastectomy Audit, in 2011, 16,485 women underwent mastectomy in the UK and this figure is increasing year-upon year (7). Problems with wound healing due to ischaemia, or lack of blood supply, after skin-sparing mastectomy (SSM) can cause significant patient morbidity and can require taking a patient back to theatre to re-operate. This prolongs length of stay (LOS), recovery time and results in significant further costs to the NHS. Skin necrosis after skin-sparing mastectomy is such a complication and current rates are around 20-40% and therefore simple, safe and cost-effective interventions that can be easily implemented into clinical practice to reduce this complication need to be researched (3-5). Local heat preconditioning is an intervention that can fulfil this need for this sometimes devastating complication and increasingly common operation. Several preconditioning methods to reduce skin necrosis have been investigated however there is a lack of clinical data and large trials (8). Methods such as thermal, pharmacological and surgical (the delay phenomenon) have all been shown to be beneficial in small studies however none have been tested in the clinical setting. Of these strategies heat preconditioning seems to be the most translatable to clinical practice. The aim of this feasibility trial is therefore to further investigate the use of heat preconditioning as a simple, non-invasive and cost-effective method of reducing skin necrosis in patients undergoing skin sparing mastectomy for breast cancer, and assess the best way to define skin necrosis that is important to patients as well as assess the feasibility of performing a trial in this population of women with this intervention. We plan to do this by conducting a 36-month single centered single bind randomized controlled trial at Guy s & St. Thomas Hospital. The results from this trial will contribute to the design of a larger definitive multi centered trial. We conducted a small, phase 1 study between 2009-2011 to investigate the putative benefits of heat preconditioning on breast cancer patients undergoing SSM and reconstruction. We recruited 25 patients and compared them to 25 controls. These patients were considered to be already at risk of developing skin necrosis as previous evidence shows that women with large breasts (over C-cup) or who are obese or who have a long sternal-notch to nipple distance are more at risk. (36). We provided these patients each with a hot water bottle, a commercially available underwater thermometer, and a specific heating protocol where they heated the breast skin the day before surgery at home. In summary, we saw a 26% reduction in skin necrosis and, unexpectedly, a reduction of length of hospital stay by four days (eight days controls, four days test subjects). The principal observation in this study was that local heat preconditioning appears to reduce skin necrosis after skin sparing mastectomy in selected patients thus providing significant benefit to the post operative recovery in these patients. Beyond skin sparing mastectomy there is potential benefit to other types of surgery and patient. For example, patients with diabetes or who are obese and about to have a procedure that could be susceptible to wound complications could benefit from heat preconditioning. Further evaluation needs to take place to quantify this benefit but heat preconditioning is an innovative and straight-forward intervention that could have a huge impact on improving post operative healing for patients and reducing costs for the NHS.At a time when financial constraints are affecting both the NHS and patients, any simple and economical intervention such as heat preconditioning has never been so important.

Lay abstract: Skin sparing mastectomy (SSM) followed by reconstruction has become the standard of care in most women needing a mastectomy for breast cancer. In 2011, 16,485 women underwent mastectomy in the UK. However, due to the delicate blood supply to the skin of the breast the postoperative wound is often susceptible to skin necrosis &ndash; where the wound breaks down due to a lack adequate blood supply. This can require a further operation resulting in delayed recovery and increased stay in hospital. SSM with reconstruction is already a costly procedure and as Reconstructive Plastic Surgeons we are interested in finding a simple and safe method of reducing the incidence of skin necrosis to improve patient recovery and to reduce the financial burden to the NHS. Experimental results have shown that applying heat to the skin before surgery can reduce the incidence of skin necrosis by improving the blood supply. In a small pilot study in our own department using hot water bottles to heat the breast skin preoperatively, we observed a 26% absolute reduction (36% to 10%) in skin necrosis in patients at risk of developing skin necrosis undergoing SSM and reconstruction. The heating was performed by the patient herself at home the night before surgery so there was no need for any additional time in hospital. Further, the average hospital stay for these patients was four days compared to eight in patients who didn t have any heat preconditioning. We believe that &ldquo;local heat preconditioning&rdquo; could be a safe and highly cost effective method of reducing skin necrosis. We will perform a single blind randomised controlled trail using hot water bottles to provide further evidence that local heat preconditioning can reduce skin necrosis rates and assess the feasibility of undertaking a large multi-centered trial.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS