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Trial registered on ANZCTR


Registration number
ACTRN12612001197820
Ethics application status
Approved
Date submitted
13/11/2012
Date registered
14/11/2012
Date last updated
15/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The application of heat to the breast before mastectomy and breast reconstruction to reduce wound healing problems.
Scientific title
Prevention of tissue necrosis in skin-sparing mastectomy using localised pre-conditioning heat therapy: a prospective pilot study
Secondary ID [1] 281531 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin necrosis 287795 0
Breast reconstruction 287796 0
Condition category
Condition code
Surgery 288147 288147 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Applying heat to the breast preoperatively using a hot-water bottle at 43 degrees centigrade. Patients were asked to heat-precondition their breast 24-hours prior to surgery using a hot water bottle with a water temperature of 43 degrees Celsius (thermometers provided), in three 30-minute cycles separated by 10 minutes of spontaneous cooling to room temperature.
Intervention code [1] 286046 0
Prevention
Comparator / control treatment
Patients who have not undergone heat preconditioning. These patients were indentified from our local database of patients that underwent immediate breast reconstruction between 2007-2009.
Control group
Historical

Outcomes
Primary outcome [1] 288352 0
Record the incidence of skin necrosis following skin sparing mastectomy that requires surgical treatment in all patients within 10 days of surgery. This is assessed by nurses and doctors on the wards who look after the patients postoperatively. There is no specific test as we check the wounds everyday for any signs of wound complications.
Timepoint [1] 288352 0
From surgery up to 10 days post-operatively.
Secondary outcome [1] 299934 0
Measure change in vascularity due to heat preconditiong using laser-doppler imaging.
Timepoint [1] 299934 0
Immediately preoperatively and after heat preconditioning
Secondary outcome [2] 299935 0
Record length of hospital stay
Timepoint [2] 299935 0
0 to 10 days

Eligibility
Key inclusion criteria
BMI above 26
Sternal-notch to nipple distance above 26 cm
Breast cup size larger than C-cup
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Below 18 years of age
Smokers

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4678 0
United Kingdom
State/province [1] 4678 0

Funding & Sponsors
Funding source category [1] 286314 0
Hospital
Name [1] 286314 0
Guy's and St. Thomas' NHS Foundation Trust
Address [1] 286314 0
Westminster Bridge Road
London
SE1 7EH
Country [1] 286314 0
United Kingdom
Primary sponsor type
Hospital
Name
Guy's and St. Thomas' NHS Foundation Trust
Address
Westminster Bridge Road
London
SE1 7EH
Country
United Kingdom
Secondary sponsor category [1] 285101 0
None
Name [1] 285101 0
Address [1] 285101 0
Country [1] 285101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288385 0
Guy's and St. Thomas' NHS Foundation Trust Ethics Committee
Ethics committee address [1] 288385 0
3rd Floor Conybeare House
Guy's Hospital
St. THomas' Street
London SE1 9RT
Ethics committee country [1] 288385 0
United Kingdom
Date submitted for ethics approval [1] 288385 0
22/03/2009
Approval date [1] 288385 0
16/07/2009
Ethics approval number [1] 288385 0
09/H0804/035

Summary
Brief summary
Background: experimental data has shown a reduction of flap necrosis after local heat application to a supraphysiological level resulting from the up-regulation of heat-shock proteins, such as HSP-32 & 70. The proteins maintained capillary perfusion and increased tissue tolerance to ischemia. The purpose of this translational study was to evaluate the effect of local heat pre-conditioning before skin-sparing mastectomy and immediate breast reconstruction.

Methods: a prospective non-randomised trial was performed from July 2009 – April 2010. 50 consecutive patients at risk of skin flap necrosis (BMI >30, sternal-to-nipple distance >26cm or breast size >C-cup) were included in the study. Twenty-five patients were asked to heat-precondition their breast 24-hours prior to surgery using a hot water bottle with a water temperature of 43 degrees centigrade (thermometers provided), in three 30-minute cycles interrupted by spontaneous cooling to room temperature. Skin flap necrosis was defined by the need for surgical debridement. LDI images were taken preoperatively to demonstrate an increase in tissue vascularity.

Results: 36% of women (n=25) without local heat-treatment experienced skin flap necrosis, 12% developed skin flap necrosis in the treatment group, (n=23; p = 0.047 (95% CI 1% to 47%)). LDI scanning of the heated breast demonstrated an increase in vascularity compared to the contralateral non-heated breast. Median length of inpatient stay for treatment group was 4 days, controls 8 days (p = <0.001).

Conclusions: the data suggests that in selected cases, local heat-preconditioning is a simple, non-invasive, and cost-effective method of reducing skin necrosis and length of hospital stay following skin-sparing mastectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34944 0
Address 34944 0
Country 34944 0
Phone 34944 0
Fax 34944 0
Email 34944 0
Contact person for public queries
Name 18191 0
Saahil Mehta
Address 18191 0
Guy's and St. Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
Country 18191 0
United Kingdom
Phone 18191 0
+442071887188
Fax 18191 0
Email 18191 0
dr.mehta@doctors.org.uk
Contact person for scientific queries
Name 9119 0
Saahil Mehta
Address 9119 0
Guy's and St. Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
Country 9119 0
United Kingdom
Phone 9119 0
+442071887188
Fax 9119 0
Email 9119 0
dr.mehta@doctors.org.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary