PREHEAT Trial - local heat preconditioning and wound healing
| ISRCTN | ISRCTN15744669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15744669 |
| Protocol serial number | 18442 |
| Sponsor | Guy’s & St Thomas’ NHS Foundation Trust & King’s College London (Comprehensive) |
| Funder | National Institute for Health Research |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Prevention |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
Added 12/06/2018: |
| Completion date | 09/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
London
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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? |
|---|---|---|---|---|---|
| Results article | results | 11/01/2019 | 18/06/2019 | Yes | No |
| Protocol article | study protocol and statistical analysis plan | 17/01/2018 | Yes | No | |
| Basic results | 19/03/2018 | 12/06/2018 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
