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The application of heat to the breast before mastectomy and breast reconstruction to reduce wound healing problems.

Prevention of tissue necrosis in skin-sparing mastectomy using localised pre-conditioning heat therapy: a prospective pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001197820
Enrollment
25
Registered
2012-11-14
Start date
2009-07-16
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Guy's and St. Thomas' NHS Foundation Trust
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

BMI above 26 Sternal-notch to nipple distance above 26 cm Breast cup size larger than C-cup

Exclusion criteria

Below 18 years of age Smokers

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 22, 2026