Plain English Summary
Not provided at time of registration
Trial website
http://reconstructivesurgerytrials.net/clinical-trials/preheat/
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18442
Study information
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
Acronym
PREHEAT
Study hypothesis
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
NRES Committee South Central - Hampshire B, 05/12/2014, ref: 14/SC/1334
Study design
Randomised; Interventional; Design type: Prevention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
09/03/2015
Overall trial end date
09/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 180; UK Sample Size: 180
Total final enrolment
141
Participant exclusion criteria
1. Any delayed (2stage) reconstruction patients
Added 05/12/2016:
2. Latex allergy
3. Inflammatory breast cancer
Recruitment start date
09/03/2015
Recruitment end date
09/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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 statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Other
Basic results (scientific)
See additional file ISRCTN15744669_BasicResults_19Mar18.pdf
Publication list
2018 study protocol and statistical analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/29375891
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30656059 (added 18/06/2019)
Publication citations
Additional files
- ISRCTN15744669_BasicResults_19Mar18.pdf Uploaded 12/06/2018