PREHEAT Trial - local heat preconditioning and wound healing

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Recruitment status:
Recruiting
Primary Sponsor:
Guy’s & St. Thomas’ NHS Foundation Trust & King’s College London (Comprehensive)
Recruitment countries:
United Kingdom
Health condition studied:
Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Cancer
URL:
Link to the clinical trial website

About the trial

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 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.
Key inclusion and exclusion 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: 1. Any delayed (2stage) reconstruction patients

    Added 05/12/2016:
    2. Latex allergy
    3. Inflammatory breast cancer
  • Age minimum: 
  • Age maximum: 
  • Gender:  Female
Primary outcomes:
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 outcomes:
Target sample size:
180
Study type:
Interventional
Study design:
Randomised; Interventional; Design type: Prevention (Treatment)
Contacts:
  • Name:  
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation: 
  • Name: Billie Coomber
  • Address:  St Thomas's Hospital 249 Westminster Bridge Road
  • Phone: 
  • Email: 
  • Affiliation: 

Technical details

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
Sources of monetary support:
National Institute for Health Research
Secondary sponsors:
Main ID:
ISRCTN15744669
Secondary ID:
18442
Register:
ISRCTN
Date of registration:
25/02/2015
Date of first enrollment:
09/03/2015
Last refreshed:
19 December 2016

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