Condition category
Cancer
Date applied
25/02/2015
Date assigned
25/02/2015
Last edited
05/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://reconstructivesurgerytrials.net/clinical-trials/preheat/

Contact information

Type

Scientific

Primary contact

Miss Billie Coomber

ORCID ID

Contact details

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

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 measures

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

N/A

Overall trial start date

09/03/2015

Overall trial end date

09/03/2017

Reason abandoned

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

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

Sponsor information

Organisation

Guy’s & St. Thomas’ NHS Foundation Trust & King’s College London (Comprehensive)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes