Effects of Negative Pressure Wound Bandaging After Mastectomy

NCT07607366 | Recruiting

• 1 other identifier: DNR-2025-00006-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Cancer - Female

Keywords

Breast cancer; Mastectomy; Negative pressure wound therapy; Seroma; Surgical site complications

Outcome Measures

Primary Outcomes (1)

• Number of participants with postoperative seroma

  Seroma was defined as clinically verified exudate in the wound cavity. The amount of seroma aspirated was measured in millilitres and the number of aspirations per participant was recorded.

  6 months

Secondary Outcomes (1)

• Surgical site complications such as, surgical site infection, hematoma, wound dehiscence and necrosis.

  6 months

Study Arms (2)

Negative pressure wound therapy

EXPERIMENTAL

PICO negative pressure wound therapy

Device: PICO negative pressure wound therapy by Smith and Nephew

Control group

NO INTERVENTION

Conventional dressings

Interventions

PICO negative pressure wound therapy by Smith and Nephew DEVICE

PICO NPWT. Dressing size 15x30cm.

Negative pressure wound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients undergoing mastectomy
• Female
• Age \>= 18 years

You may not qualify if:

• Direct reconstruction with implants
• The use of Harmonic Johnson and Johnson instrument during surgery

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead

Study Sites (1)

Falu Lasarett

Falun, 79182, Sweden

RECRUITING

Related Publications (17)

• Tormey S, Earley H, Sloan S, Mathers H, Varzgalis M, Wahab SAE, et al. The role of prophylactic, single-use, negative pressure wound therapy dressings in wound management following breast surgery. Wounds International. 2021;12(4):30-36.

  BACKGROUND

• Hershman DL, Wang X, McBride R, Jacobson JS, Grann VR, Neugut AI. Delay of adjuvant chemotherapy initiation following breast cancer surgery among elderly women. Breast Cancer Res Treat. 2006 Oct;99(3):313-21. doi: 10.1007/s10549-006-9206-z. Epub 2006 Apr 1.

  PMID: 16583264 BACKGROUND

• Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31.

  PMID: 23346164 BACKGROUND

• Ryu JY, Lee JH, Kim JS, Lee JS, Lee JW, Choi KY, Chung HY, Cho BC, Yang JD. Usefulness of Incisional Negative Pressure Wound Therapy for Decreasing Wound Complication Rates and Seroma Formation Following Prepectoral Breast Reconstruction. Aesthetic Plast Surg. 2022 Apr;46(2):633-641. doi: 10.1007/s00266-020-02115-0. Epub 2021 Jan 20.

  PMID: 33474573 BACKGROUND

• Tanaydin V, Beugels J, Andriessen A, Sawor JH, van der Hulst RRWJ. Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality. Aesthetic Plast Surg. 2018 Aug;42(4):927-935. doi: 10.1007/s00266-018-1095-0. Epub 2018 Feb 13.

  PMID: 29442143 BACKGROUND

• Tang N, Li H, Chow Y, Blake W. Non-operative adjuncts for the prevention of mastectomy skin flap necrosis: a systematic review and meta-analysis. ANZ J Surg. 2023 Jan;93(1-2):65-75. doi: 10.1111/ans.18146. Epub 2022 Nov 14.

  PMID: 36373495 BACKGROUND

• Wareham CM, Karamchandani MM, Ku GC, Gaffney K, Sekigami Y, Persing SM, Homsy C, Nardello S, Chatterjee A. Closed Incision Negative Pressure Therapy in Oncoplastic Breast Surgery: A Comparison of Outcomes. Plast Reconstr Surg Glob Open. 2023 Apr 25;11(4):e4936. doi: 10.1097/GOX.0000000000004936. eCollection 2023 Apr.

  PMID: 37113306 BACKGROUND

• Fogacci T, Cattin F, Semprini G, Frisoni G, Fabiocchi L, Samorani D. The negative pressure therapy with PICO as a prevention of surgical site infection in high-risk patients undergoing breast surgery. Breast J. 2020 May;26(5):1071-1073. doi: 10.1111/tbj.13659. Epub 2019 Oct 19. No abstract available.

  PMID: 31628760 BACKGROUND

• Vidya R, Khosla M, Baek K, Vinayagam R, Thekkinkattil D, Laws S, Douvetzemis S, Sircar T, Mullapudi A, Murphy J. Prophylactic Use of Negative Pressure Wound Therapy in High-risk Patients Undergoing Oncoplastic and Reconstructive Breast Surgery. Plast Reconstr Surg Glob Open. 2023 Dec 19;11(12):e5488. doi: 10.1097/GOX.0000000000005488. eCollection 2023 Dec.

  PMID: 38115832 BACKGROUND

• Groenen H, Jalalzadeh H, Buis DR, Dreissen YEM, Goosen JHM, Griekspoor M, Harmsen WJ, IJpma FFA, van der Laan MJ, Schaad RR, Segers P, van der Zwet WC, de Jonge SW, Orsini RG, Eskes AM, Wolfhagen N, Boermeester MA. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis. EClinicalMedicine. 2023 Jul 24;62:102105. doi: 10.1016/j.eclinm.2023.102105. eCollection 2023 Aug.

  PMID: 37538540 BACKGROUND

• Buchholz TA, Austin-Seymour MM, Moe RE, Ellis GK, Livingston RB, Pelton JG, Griffin TW. Effect of delay in radiation in the combined modality treatment of breast cancer. Int J Radiat Oncol Biol Phys. 1993 Apr 30;26(1):23-35. doi: 10.1016/0360-3016(93)90169-v.

  PMID: 8482628 BACKGROUND

• Thalji SZ, Cortina CS, Guo MS, Kong AL. Postoperative Complications from Breast and Axillary Surgery. Surg Clin North Am. 2023 Feb;103(1):121-139. doi: 10.1016/j.suc.2022.08.007. Epub 2022 Oct 18.

  PMID: 36410345 BACKGROUND

• Cagney D, Simmons L, O'Leary DP, Corrigan M, Kelly L, O'Sullivan MJ, Liew A, Redmond HP. The Efficacy of Prophylactic Negative Pressure Wound Therapy for Closed Incisions in Breast Surgery: A Systematic Review and Meta-Analysis. World J Surg. 2020 May;44(5):1526-1537. doi: 10.1007/s00268-019-05335-x.

  PMID: 31900568 BACKGROUND

• Esen E, Morkavuk SB, Turan M, Akyuz S, Guler S, Akgul GG, Bahcecioglu IB, Gulcelik MA, Yilmaz KB. The use of incisional negative pressure wound therapy on high-risk breast cancer mastectomy patients. Asian J Surg. 2024 Aug 19:S1015-9584(24)01706-8. doi: 10.1016/j.asjsur.2024.07.333. Online ahead of print.

  PMID: 39164174 BACKGROUND

• De Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation. Sci Rep. 2021 May 5;11(1):9620. doi: 10.1038/s41598-021-89036-3.

  PMID: 33953312 BACKGROUND

• World Health Organization [Internet]. 2025 [cited 2025 Sep 10]. Breast cancer. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer

  BACKGROUND

• Regionala cancercentrum i samverkan. Bröstcancer Nationellt vårdprogram. Stockholm: Regionala cancercentrum i samverkan; 2024. Version: 5.1.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Region Dalarna

  STUDY DIRECTOR

Central Study Contacts

Rebecca Paul, Dr

CONTACT

023-490000; rebecca.paul@regiondalarna.se

Erika Bengtsson, Dr

CONTACT

023490000; erika.bengtsson@regiondalarna.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single center randomized-controlled trial

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

SE (1)