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Participant information sheet Mastectomy is a surgical method used to treat breast cancer. A mastectomy involves the removal of the entire breast. A common postoperative complication after a mastectomy is seroma, i.e. an abnormal accumulation of serous fluid in the wound cavity. At present, at Falu Lasarett, we use conventional dressings on the wound after the operation as well as an active drainage that is left in place for a couple of days. There is research that suggests that negative pressure dressings can promote wound healing and reduce the formation of seroma. The purpose of this study is to investigate whether negative pressure dressings reduce the risk of postoperative seroma compared to regular dressings. We will also look at whether it reduces the risk of other postoperative complications such as infection, bleeding and wound healing problems. We are asking all patients who will undergo a mastectomy in 2025 if they want to participate in our study. The Director of Research, Education and Innovation is the authorized representative of the research principal (which is the legal entity Region Dalarna). Research principal means the organization responsible for the project. The research is approved by the Ethics Review Authority, the registry number for the trial at the Ethics Review Authority is 2025-00006-01. How does the project work? Participating in our study means that on the day of surgery you will be randomized between two groups. One group will receive conventional wound dressings, and the other group will receive PICO negative pressure dressings. The negative pressure dressing is connected to a small canister that is worn for 7 days. Just like today, there will be a return visit to the nurse in the surgery ward after a day to check and possibly remove the active drain. There will also be a return visit to the doctor after 2-3 weeks for results of the tissue analysis and information about further treatment. The additional visit if you participate in our study is a return visit to the nurse after 7 days to remove the PICO negative pressure dressing (if you belong to that group). A return visit to the nurse is also planned after 6 months as a follow-up. If you have any questions or problems, you can contact your contact nurse. Possible consequences and risks of participating in the project The PICO negative pressure dressing is connected to a cord with a small canister that must be carried with you. The canister fits in a pocket. The canister is on 24 hours a day and emits a light vibration sound. What happens to your data? The project will collect and register information about you. Information about your medical history, measurements, medications, type of surgical procedure, number of return visits after surgery and postoperative complications will be collected from your medical record to analyze our results. The data will be pseudonymized and entered into a password-protected Excel document for analysis. The code key is stored in a lock-protected Excel file. The code key is processed so that unauthorized persons cannot access it. Your answers and your results will be processed so that unauthorized persons cannot access them. The code key and research data are stored for 10 years in accordance with research ethics because it should be possible to go back to the research data and re-analyze if question marks arise about our analysis methods. The data protection officer of Region Dalarna is responsible for your personal data. According to the EU Data Protection Regulation, you have the right to access the data about you that is handled in the project free of charge, and to have any errors corrected if necessary. You can also request that data about you be deleted and that the processing of your personal data be restricted. However, the right to deletion and restriction of processing of personal data does not apply when the data is necessary for the current research. If you would like to access the data, please contact the principal investigator (Rebecca Paul, rebecca.paul@regiondalarna.se, 023 490760). The data protection officer can be reached at dataskyddsombud@regiondalarna.se, Tel: 023-490000. If you are dissatisfied with how your personal data is processed, you have the right to file a complaint with the Swedish Data Protection Authority, which is the supervisory authority. How do you get information about the results of the project? You can access your individual data in your medical record. The results of the entire study will be reported internally at Kirurgkliniken Falu Lasarett and are intended to be published in a scientific journal. Unforeseen findings will be handled through follow-up and, if necessary, treatment. Insurance and compensation Patient insurance valid through the research principal. You will not receive compensation as the study is part of a planned procedure. Participation is voluntary.
Project Plan
Title Is negative pressure wound therapy associated with a decreased risk of postoperative seroma in breast cancer patients who have undergone mastectomy?
Introduction Breast cancer is the most common cancer in women in Sweden as well as globally. In 2022, there were 2,3 million women diagnosed with breast cancer and 670 000 deaths globally (1). More than every tenth woman in Sweden will suffer from breast cancer during their lifetime. Since the 1970s the 10 year survival rate in Sweden has increased from around 54% to 88% and the 5 year survival rate has increased from around 69% to 93% (2).
There are two main types of surgical treatment for breast cancer, breast-conserving surgery and mastectomy. The number of mastectomies have gradually decreased because of decreased tumor size at diagnosis and an increased use of oncoplastic surgery and preoperative treatment. However, it still has an important role with indications like: inflammatory tumor, T4-tumor after preoperative treatment, large tumors that progress during preoperative treatment, local recurrence after previous partial mastectomy with radiotherapy, multicentric tumors, persisting positive margins after extended excision after partial mastectomy or contraindications for postoperative radiotherapy (2).
Wound complications after mastectomy such as surgical site infections (SSI), seromas, wound dehiscence, wound necrosis and hematoma are a frequently occurring problem (3, 4). The complications are a major cause of morbidity for patients and a significant cost burden for healthcare providers. Surgical site complications in breast cancer patients can also delay the initiation of adjuvant treatment and may negatively impact both recurrence risk and overall survival (4, 5).
There is research showing that Negative Pressure Wound Therapy (NPWT) reduces the risk for SSI with up to 33% compared to standard care, over a range of surgical specialties (6). It is also a promising technique for preventing and managing wound complications in high-risk closed incisions (3). NPWT is thought to reduce bacterial contamination, exudate and edema, promote lymphatic and local blood flow, and stimulate tissue granulation. No significant difference has been observed between -80mmHg and -125mmHg devices (6).
A systematic review and meta-analysis by Cagney et al has shown that prophylactic application of NPWT is associated with significantly fewer surgical site complications including SSI, seroma, wound dehiscence and wound necrosis for closed breast incisions in breast surgery, compared with conventional non-NPWT dressings, while there was no significant difference in rates of hematoma (5). A meta-analysis by Song et al showed similar results, however, with no significant difference in rates of seroma (7).
A range of studies looking at NPWT in various types of oncoplastic and reconstructive breast surgeries suggest an association with reduced postoperative wound complications (8-11). Some key findings are reduced mastectomy flap necrosis in skin-sparing and nipple-sparing mastectomy (12), improvement in quality of scarring in bilateral reduction mammoplasty (13), reduced development of major seroma, as well as reduced duration and total volume of seroma in prepectoral breast reconstruction (14). The cost-effectiveness of NPWT for reducing complications after breast surgery (8), especially in high-risk patients (9), has also been implied.
Looking at mastectomies specifically, a study by De Rooij et al evaluated postoperative wound complications following the use of NPWT in patients undergoing mastectomy. They suggested that it neither leads to fewer postoperative wound complications, nor leads to fewer patients requiring unplanned visits or fewer patients with clinically significant seroma (3). Esen et al, however, compared NPWT to conventional dressings in modified radical mastectomy (mastectomy + axillary lymph nodes) in high-risk patients and suggested that NPWT significantly reduced postoperative seroma, flap ischemia and flap dehiscence. No difference was determined regarding postoperative hematoma, flap necrosis and SSI (4).
Knowledge gap To summarize, there is limited research with contradictory results on whether NPWT decreases the risk of postoperative seroma and surgical site complications in patients who have undergone mastectomy.
Aim The aim of our study is to assess if PICO NPWT affects the risk of postoperative seroma in breast cancer patients who have undergone mastectomy compared to conventional dressings.
Hypothesis We hypothesize that PICO NPWT reduces the risk of postoperative seroma in breast cancer patients who have undergone mastectomy.
Material and methods Study design This is a randomized controlled trial comparing PICO negative pressure wound therapy to conventional dressings in breast cancer patients who have undergone mastectomy.
Setting It is a pilot single-center study at the district hospital Falu Lasarett in Sweden. The data collection will take place from Mars 2025 - September 2026. Data regarding patient characteristics and postoperative complications will be extracted from patient records.
Study size We will have a sample size of 64 patients based on power calculations (32 patients in the control group and 32 patients in the intervention group). Power calculations were based on 50% anticipated incidence of seroma in the control group, 10% anticipated incidence of seroma in the intervention group, a power of 90%, a P-value of 0.05 (alpha) and compensation of 20% loss to follow-up.
PICO NPWT PICO NPWT by Smith and Nephew will be used. The dressing size is 15 x 30cm. It will be applied directly on the skin in the operating theater. It is attached to a small device which is turned on continuously for 7 days and can be carried around in a pocket. It may only be paused for showers. Active drainage needs to be placed outside the dressing. If the patient has a pacemaker the device needs to be placed 10 cm apart. Contraindications for the PICO NPWT include oversensitivity to silicone and active bleeding.
Patient description Eligibility criteria
Exclusion criteria:
Source and method of participant selection All patients with a newly diagnosed breast cancer come to the specialized surgical outpatient clinic for a primary visit to discuss their diagnosis and surgical treatment plan. They meet a breast surgeon and a contact nurse. All cases are discussed at a multidisciplinary conference. All breast cancer patients who are planned for a mastectomy will be offered to participate in the study. The type of wound dressing will be randomized during each surgery (by a program on the computer in the operation theatre). Baseline data will be recorded before randomization.
Type of data Outcome The primary outcome is postoperative seroma. We define seroma as clinically verified exudate in the wound cavity. The amount of seroma aspirated will be measured and recorded. The secondary outcome is other surgical site complications such as, surgical site infection, hematoma, wound dehiscence and necrosis. The follow up time will be 6 months. The outcomes will be measured by follow-up appointments at the outpatient clinic.
Standard care today includes the following visits to the outpatient clinic:
The extra visits related to this study will be:
Exposure PICO negative pressure wound therapy or conventional dressings.
Covariates High-risk groups include: BMI >30, smoking, diabetes, corticosteroids, anticoagulants, neoadjuvant chemotherapy, previous radiotherapy and immunosuppressive therapy. Age, sentinel node biopsy, axillary lymph node dissection and ASA classification will be noted.
Statistical methods and analyses The Statistical Programme SPSS will be used and the statistical analyses will be conducted by an external statistician from CKF Dalarna.
Ethical permit and review We have applied for an Ethical permit via Etikprövningens Myndighet (the Swedish Ethical Review Board). Ethical approval has been obtained with the approval number/ID 2025-00006-01. Patient data will be handled anonymously. Patients offered to participate in the study will sign a waiver of informed consent.
Funding Funding through surgical residency project.
References
Supervisor Rebecca Paul rebecca.paul@regiondalarna.se
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure wound therapy | Experimental | PICO negative pressure wound therapy |
|
| Control group | No Intervention | Conventional dressings |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO negative pressure wound therapy by Smith and Nephew | Device | PICO NPWT. Dressing size 15x30cm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroma development in wound after mastectomy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site complications such as, surgical site infection, hematoma, wound dehiscence and necrosis. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Paul, Dr | Contact | 023-490000 | rebecca.paul@regiondalarna.se | |
| Erika Bengtsson, Dr | Contact | 023490000 | erika.bengtsson@regiondalarna.se |
| Name | Affiliation | Role |
|---|---|---|
| Region Dalarna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falu Lasarett | Recruiting | Falun | 79182 | Sweden |
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Single center randomized-controlled trial
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