PREHEAT Trial - local heat preconditioning and wound healing
| ISRCTN | ISRCTN15744669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15744669 |
| Secondary identifying numbers | 18442 |
- Submission date
- 25/02/2015
- Registration date
- 25/02/2015
- Last edited
- 18/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Billie Coomber
Scientific
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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 |
| Study acronym | PREHEAT |
| Study objectives | 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(s) | NRES Committee South Central - Hampshire B, 05/12/2014, ref: 14/SC/1334 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 09/03/2015 |
| Completion date | 09/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 180; UK Sample Size: 180 |
| Total final enrolment | 141 |
| Key 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 |
| Key exclusion criteria | 1. Any delayed (2stage) reconstruction patients Added 05/12/2016: 2. Latex allergy 3. Inflammatory breast cancer |
| Date of first enrolment | 09/03/2015 |
| Date of final enrolment | 09/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE1 7EH
United Kingdom
Sponsor information
Guy’s & St Thomas’ NHS Foundation Trust & King’s College London (Comprehensive)
Hospital/treatment centre
Hospital/treatment centre
Imaging Sciences
The Rayne Institute
Lambeth Wing - 4th floor St Thomas' Hospital
London
SE1 7EH
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. Added 12/06/2018: The manuscript is currently under peer review. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol and statistical analysis plan | 17/01/2018 | Yes | No | |
| Basic results | 19/03/2018 | 12/06/2018 | No | No | |
| Results article | results | 11/01/2019 | 18/06/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN15744669_BasicResults_19Mar18.pdf
- Uploaded 12/06/2018
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/06/2018: The secondary outcome measures, publication and dissemination plan, and IPD sharing statement were added. The basic results of this trial have been uploaded as an additional file.
14/02/2018: Publication reference added.
29/01/2018: Publication reference added.
