Effects of Negative Pressure Wound Bandaging After Mastectomy

Summary

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, [email protected], 023 490760). The data protection officer can be reached at [email protected], 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.

Conditions

• Breast Cancer - Female

Interventions

DEVICE

PICO negative pressure wound therapy by Smith and Nephew

PICO NPWT. Dressing size 15x30cm.

Sponsors & Collaborators

• Dalarna County Council, Sweden

  lead OTHER

Principal Investigators

• Region Dalarna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2027-03-01

Completion

2027-09-01

Countries

• Sweden

Study Locations