Topic: Cancer
Conditions
Interventions
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
Sponsors
Guy’s & St Thomas’ NHS Foundation Trust & King’s College London (Comprehensive)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Any delayed (2stage) reconstruction patients Added 05/12/2016: 2. Latex allergy 3. Inflammatory breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed