Is Negative Pressure Wound Therapy Associated With a Decreased Risk of Postoperative Seroma in Breast Cancer Patients Who Have Undergone Mastectomy?

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 Falun regional hospital, conventional dressings are used 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. The investigators will also look at whether it reduces the risk of other postoperative complications such as infection, bleeding and wound healing problems. The investigators are asking all patients who will undergo a mastectomy in 2025 if they want to participate in the 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.

Participating in the study means that on the day of surgery participants 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 for participants in the study is a return visit to the nurse after 7 days to remove the PICO negative pressure dressing (if the participant belongs to that group). A return visit to the nurse is also planned after 6 months as a follow-up. If participants have any questions or problems, participants can contact the contact nurse. The PICO negative pressure dressing is connected to a cord with a small canister that must be carried with the participant. The canister fits in a pocket. The canister is on 24 hours a day and emits a light vibration sound. The project will collect and register information about participants. Information about participant medical history, measurements, medications, type of surgical procedure, number of return visits after surgery and postoperative complications will be collected from participants medical record to analyze the 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. Participants answers and 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 parti personal data. According to the EU Data Protection Regulation, participants have the right to access the data that is handled in the project free of charge, and to have any errors corrected if necessary. Participants can also request that data about them be deleted and that the processing of participants 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 participants 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 participants are dissatisfied with how their personal data is processed, they have the right to file a complaint with the Swedish Data Protection Authority, which is the supervisory authority. Participants can access their individual data in their medical record. The results of the entire study will be reported internally at Kirurgkliniken Falun regional hospital and are intended to be published in a scientific journal. Unforeseen findings will be handled through follow-up and, if necessary, treatment. Patient insurance valid through the research principal. Participants will not receive compensation as the study is part of a planned procedure. Participation is voluntary.