PREHEAT Trial - local heat preconditioning and wound healing

ISRCTN	ISRCTN15744669
DOI	https://doi.org/10.1186/ISRCTN15744669
Secondary identifying numbers	18442

Submission date: 25/02/2015
Registration date: 25/02/2015
Last edited: 18/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Miss Billie Coomber
Scientific

St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Study information

Study design	Randomised; Interventional; Design type: Prevention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific 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
Study acronym	PREHEAT
Study objectives	The aim of this study is to evaluate local heat preconditioning with respect to its effects on wound healing after reconstructive breast surgery in patients with breast cancer.
Ethics approval(s)	NRES Committee South Central - Hampshire B, 05/12/2014, ref: 14/SC/1334
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Intervention	The intervention is heat preconditioning the breast over the nipple-areola complex. The heat will be delivered by hot water bottles at a temperature of 43degC in three thirty minute cycles interrupted by 30-minute breaks where the breast is allowed to cool. The control group will not be required to perform any intervention. The follow up will be via clinical assessment of healing.
Intervention type	Other
Primary outcome measure	Development of skin necrosis of the breast post operatively, measured by clinical assessment (area of necrosis measured in mm2) on post-operative days 1-30
Secondary outcome measures	Added 12/06/2018: 1. Recruitment rate (number randomised/number eligible) 2. 30-40 day follow-up rate 3. Level of compliance with heating protocol 4. Length of hospital stay 5. Rates of surgical/conservative management of skin necrosis - necrosis was measured at the first outpatient appointment (usually day 12-16) until 30-40 days post surgery
Overall study start date	09/03/2015
Completion date	09/03/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 180; UK Sample Size: 180
Total final enrolment	141
Key inclusion criteria	1. All females over the age of 18 2. Patients undergoing skin sparing mastectomy and immediate breast reconstruction (autologous & implant) 3. All diabetics, smokers and postradiotherapy patients will be included 4. All BRCA carrier prophylactic mastectomies with immediate breast reconstruction Added 05/12/2016: 5. Patients undergoing nipple-sparing mastectomy
Key exclusion criteria	1. Any delayed (2stage) reconstruction patients Added 05/12/2016: 2. Latex allergy 3. Inflammatory breast cancer
Date of first enrolment	09/03/2015
Date of final enrolment	09/03/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Thomas's Hospital

249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Guy’s & St Thomas’ NHS Foundation Trust & King’s College London (Comprehensive)
Hospital/treatment centre

Imaging Sciences
The Rayne Institute
Lambeth Wing - 4th floor St Thomas' Hospital
London
SE1 7EH
England
United Kingdom

"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	We are intending to publish in 2017 in a scientific journal. We also plan to disseminate our results via the patient support groups for breast reconstruction. Added 12/06/2018: The manuscript is currently under peer review.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	study protocol and statistical analysis plan	17/01/2018		Yes	No
Basic results		19/03/2018	12/06/2018	No	No
Results article	results	11/01/2019	18/06/2019	Yes	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN15744669_BasicResults_19Mar18.pdf: Uploaded 12/06/2018

Editorial Notes

The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/06/2018: The secondary outcome measures, publication and dissemination plan, and IPD sharing statement were added. The basic results of this trial have been uploaded as an additional file.
14/02/2018: Publication reference added.
29/01/2018: Publication reference added.