PREHEAT Trial - local heat preconditioning and wound healing
Research type
Research Study
Full 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
IRAS ID
146334
Contact name
Saahil Mehta
Contact email
Sponsor organisation
Guy's & St. Thomas' NHS Foundation Trust
ISRCTN Number
15744669
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
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 – 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 “local heat preconditioning” 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.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1334
Date of REC Opinion
5 Dec 2014
REC opinion
Further Information Favourable Opinion