Plain English Summary
Background and study aims
The vital component of mastectomy and immediate breast reconstruction is the viability of the preserved skin envelope (with a healthy blood supply) once the underlying breast tissue is excised. Any trauma and compromise of skin vascularity can lead to complications such as infection, skin necrosis and reconstruction failure.
To reduce complications, different interventional methods in mastectomy and immediate breast reconstruction have been tried to prevent post-surgery infections, but none have been widely adopted.
Using a gentle technique to lift the soft tissue could decrease post-surgery infection and reduce patient re-admission and re-operation. To enable a clear view of the operative field during surgery, surgical tools called retractors are used to forcefully lift tissue to allow access for the surgeon. The forceful lift can contribute to tissue injury and consequent complications.
This study represents an opportunity to compare tissue perfusion during breast mastectomy when using metal retractors versus fingers to lift the tissue.
Who can participate?
The study population are women 18 years of age and over, undergoing bilateral mastectomy with immediate reconstruction.
What does the study involve?
Once eligibility is confirmed the research team at the routine outpatient visit, will give a pre-operative questionnaire to be complete before surgery. On the surgery day, the surgeon will undertake the double mastectomy with breast reconstruction procedure using the retractor method in one breast and the non-retractor method (fingers) in the other breast. During the surgery, the anaesthetist will inject small amounts of the fluorescent tracer agent called Indocyanine (ICG) dye into a vein at three different time points in each breast, and at each timepoint record the tissue perfusion (%) so the difference in the blood flow between both techniques at the three different time points can be compared.
After surgery, pain scores will be collected for each breast at 18hour then again at follow up week 1, week 2 and week 4-6, during these follow up visits the research team will also collect information regarding the secondary outcomes. At follow-up week 4-6, the participant will be also asked to complete a post-operative questionnaire.
What are the possible benefits and risks of participating?
There will be no direct benefit for the participants.
The risks associated to the study remain the same as with routine surgery, as the different surgical techniques used in this study are widely used by surgeons already, however the injection of the ICG dye is not part of the routine procedure and could be a risk of reaction to it. The information collected may benefit patients with breast cancer or at risk of breast cancer in the future.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2023 to March 2025
Who is funding the study?
Addenbrookes Charitable Trust (ACT) (UK)
Innovate UK
Who is the main contact?
Alexandra Azevedo, alex.azevedo@nhs.net
Study website
Contact information
Type
Scientific
Contact name
Dr Alexandra Azevedo
ORCID ID
Contact details
Cambridge Clinical Trial Centre
S4 block
Addenbrookes Hospital
Hills Road
Cambridge
CB1 0QQ
United Kingdom
+44 1223 348 454
alex.azevedo@nhs.net
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
330226
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 57311, Grant codes 10073306 / 10073066, IRAS 330226
Study information
Scientific title
A Prospective Case-control Study to Compare Tissue Perfusion between RetrActors and Non-retractors during Immediate Breast ReConstruction
Acronym
PerfAct BreCon
Study hypothesis
Current Study hypothesis as of 25/03/2024:
There will be a difference in the surgery outcomes between the two tissue spread techniques used in each breast.
_____
Previous Study hypothesis:
There will be a difference in performance between the two retractors
Ethics approval(s)
Approved 22/12/2023, East of Scotland Research Ethics Service (EoSRES) (Tayside medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9SY, United Kingdom; no telephone number provided; tay.eosres@nhs.scot), ref: 23/ES/46
Study design
Interventional case-controlled study
Primary study design
Interventional
Secondary study design
Case-controlled study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Breast surgery
Intervention
Current interventions as of 25/03/2024:
Pre surgery:
The patient will be given the applicable modules of the BREAST-Q Reconstruction version 2.0 questionnaire to complete before their surgery takes place.
Surgery:
The mastectomy with immediate reconstruction will be undertaken as per usual local procedures. During the surgery, the anaesthetist will inject small amounts of the fluorescent tracer agent called Indocyanine (ICG) dye into a vein at three different time points in each breast. This will happen once at the beginning of surgery, once when the surgeon switches from using the non-retractor method (fingers) to metal retractors and then again at the end of the surgery. These measurements will be made in the same way in the other breast as well so the difference in the blood flow between both techniques at the three different time points can be compared.
Post surgery:
18hrs post surgery the research team will collect the pain scores from the patient for each of the breasts. Patients will be followed up during their routine clinic visits/consultation, with clinical data collection time points approximating to 1 week, 2 weeks and 4-6 weeks post surgery. At these visits the research team will collect the pain scores for each breast, information about any surgery-related adverse events the patient has experienced, information regarding re-admissions and/or re-operation. At the last post-operative time point of 4-6 weeks the patient will be given the post-operative modules of the BREAST-Q Reconstruction questionnaire to complete.
_____
Previous interventions:
Pre surgery:
The patient will be given the applicable modules of the BREAST-Q Reconstruction version 2.0 questionnaire to complete before their surgery takes place.
Surgery:
During the mastectomy, the surgeon will request to the anesthetist to inject dye into the patient and then the surgeon will measure the tissue perfusion using a Stryker’s SPY-PHI handheld imager device at three time-points for each breast. Two different techniques will be used during surgery - non-retractors (finger dissection) in the right breast and retractors in the left breast- in order to have vision and access to the tissue to be removed. After the surgery, patients will be asked to score their pain level in each breast at four different time points; this will be either in person prior to discharge or over the telephone post-discharge.
Post surgery:
Patients will be followed up during their routine clinic visits/consultation, with clinical data collection time points approximating to 1 week, 2 weeks and 4-6 weeks post surgery. At these visits the research team will collect the pain scores for each breast, information about any surgery-related adverse events the patient has experienced, information regarding re-admissions and/or re-operation. At the last post-operative time point of 4-6 weeks the patient will be given the post-operative modules of the BREAST-Q Reconstruction questionnaire to complete.
End of trial:
End of the study will be when the last patient recruited has completed the last follow-up.
Intervention type
Procedure/Surgery
Primary outcome measure
Current primary outcome measure as of 25/03/2024:
The relative difference (%) in blood perfusion between each breast in the same patient. Blood perfusion will be measured at 3 time-points (T1: baseline, T2: mid-point, T3: end) during the mastectomy procedure. The relative difference is defined as the difference, D, of Blood perfusion at T2-T1. The t-test will be applied on the between-breast difference on D.
_____
Previous primary outcome measure:
Blood perfusion will be measured using the SPY-PHI device (%) at 3 time-points (T1: baseline, T2: mid-point, T3: end).
Secondary outcome measures
1. Patient hospital re-admission, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6
2. Patient hospital stay duration, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6
3. Patient re-operation required, where applicable; assessed trough a questionnaire to the patient at time points: Follow up week 1, week 2 and week 4-6
4. Patient-reported post-surgery pain scores assessed on a numerical pain score at the following time points: 18hrs, follow-up week 1, week 2 and week 4-6
5. Incidence, type and severity of surgery related adverse events, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6
6. Comparison of patients' pre- and post-surgery outcomes measured in a numerical scale of the BREAST-Q Recon version 2.0 questionnaire (Modules 7, 8, 9 and 14), at follow up week 4-6
Overall study start date
21/04/2023
Overall study end date
31/03/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 25/03/2024:
1. Signed informed consent form
2. Female aged 18 years old or above
3. Needing bilateral mastectomy for either:
3.1. Bilateral breast cancer, or
3.2. Risk reduction (due to pathological gene mutation or high-risk family history or previous mantle radiotherapy for lymphoma).
4. Undergoing bilateral mastectomy concurrently with immediate breast reconstruction on both sides
5. Undergoing the same type of breast reconstruction on both sides
6. Adequate liver function where bilirubin is ≤1.5 x ULN
7. Adequate renal function with a serum creatinine ≤ 1.5 x ULN
8. Willing and able to comply with scheduled visits and study procedures for the duration of the study.
_____
Previous inclusion criteria:
1. Signed informed consent form
2. Female aged 18 years old or above
3. Bilateral breast cancer
4. Needing bilateral mastectomy for breast cancer or for risk reduction (due to pathological gene mutation or high-risk family history or previous mantle radiotherapy for lymphoma)
5. Undergoing bilateral mastectomy concurrently with immediate breast reconstruction
6. Undergoing the same type of breast reconstruction on both sides
7. Adequate liver function where bilirubin is < = 1.5 x ULN
8. Adequate renal function with a serum creatinine < = 1.5 x ULN
9. Willing and able to comply with scheduled visits and study procedures for the duration of the study.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
30
Participant exclusion criteria
Current exclusion criteria as of 25/03/2024:
1. Locally advanced breast cancer with skin involvement
2. Previous unilateral breast radiotherapy (if mastectomy is for local recurrence)
3. Previous significant unilateral breast surgery (such as reduction) judged by the recruiting/operating surgeon to have adversely affected breast supply on that side
4. Known allergies or hypersensitivity to indocyanine green (ICG) dye, sodium iodide or iodine or having experienced previous side-effects of ICG dye or its components
5. Patients with an overactive thyroid or benign tumours of the thyroid gland
6. Patients with severe renal insufficiency
7. Women who are pregnant, plan to become pregnant, or are lactating during the study period.
_____
Previous exclusion criteria:
1. Unilateral breast cancer
2. Undergoing unilateral mastectomy
3. Not undergoing immediate breast reconstruction
4. Locally advanced breast cancer with skin involvement
5. Previous unilateral breast radiotherapy (if mastectomy is for local recurrence)
6. Previous significant unilateral breast surgery (such as reduction) judged by the recruiting/operating surgeon to have adversely affected breast blood supply on that side
7. Known allergies or hypersensitivity to indocyanine green (ICG) dye, sodium iodide or iodine or having experienced previous side-effects of ICG dye or its components
8. Patients with an overactive thyroid or benign tumours of the thyroid gland
9. Patients with severe renal insufficiency
10. Women who are pregnant, plan to become pregnant, or are lactating during the study period
Recruitment start date
06/03/2024
Recruitment end date
31/01/2025
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust
Sponsor details
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
+44 1223 217418
cuh.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
Innovate UK
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The main study results may be presented at national and international conferences and published in a peer-reviewed journal, on behalf of all collaborators. All presentations and publications relating to the study must be authorised by the SMG.
The manuscript will be prepared by a writing group appointed from amongst the SMG and high-accruing investigators. The CCTU-CT, ACT and Innovate UK and all Investigators will be acknowledged in publications and presentations. Senior authorship shall be shared between members of the SMG according to their leadership role in the trial. Priority will be given to the lead scientific and clinical teams co-ordinating the trial.
Intention to publish date
31/03/2026
Individual participant data (IPD) sharing plan
The current data sharing plans for this study are unknown and will be available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 18/12/2023 | 07/03/2024 | No | No |
| Protocol file | version 2.0 | 22/02/2024 | 25/03/2024 | No | No |