Effects of Negative Pressure Wound Bandaging After Mastectomy

Официальное название

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

Обзор

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.

Подробное описание

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. 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%.

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.

Wound complications after mastectomy such as surgical site infections (SSI), seromas, wound dehiscence, wound necrosis and hematoma are a frequently occurring problem. 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.

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. It is also a promising technique for preventing and managing wound complications in high-risk closed incisions. 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.

A systematic review and meta-analysis 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. A meta-analysis showed similar results, however, with no significant difference in rates of seroma.

A range of studies looking at NPWT in various types of oncoplastic and reconstructive breast surgeries suggest an association with reduced postoperative wound complications. Some key findings are reduced mastectomy flap necrosis in skin-sparing and nipple-sparing mastectomy, improvement in quality of scarring in bilateral reduction mammoplasty, reduced development of major seroma, as well as reduced duration and total volume of seroma in prepectoral breast reconstruction. The cost-effectiveness of NPWT for reducing complications after breast surgery, especially in high-risk patients, has also been implied.

Looking at mastectomies specifically, a study 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. However, another study 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.

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 the 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 The investigators hypothesize that PICO NPWT reduces the risk of postoperative seroma in breast cancer patients who have undergone mastectomy.

Material and methods Setting Data regarding patient characteristics and postoperative complications will be extracted from patient records.

Study size The investigators will have a sample size of 76 patients based on power calculations (38 patients in the control group and 38 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.

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, after the surgery is finished and before wound dressings are applied. Baseline data will be recorded before randomization.

Type of data The outcomes will be measured by follow-up appointments at the outpatient clinic.

Standard care today includes the following visits to the outpatient clinic:

* Follow up after 1 day with a contact nurse to remove active drainage. * Follow up after 2-3 weeks with a surgeon to receive the pathology report and continued treatment plan decided at the multidisciplinary conference.

The extra visits related to this study will be:

* Follow up after 7 days with a contact nurse for the intervention group to remove the PICO negative pressure wound therapy. * Follow up after 6 months with a contact nurse for both groups (control group and intervention group).

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.

Funding Funding through surgical residency project.

Вмешательства

• Устройство PICO negative pressure wound therapy by Smith and Nephew
  PICO NPWT. Dressing size 15x30cm.

Первичные конечные точки

• Number of participants with postoperative seroma [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Surgical site complications such as, surgical site infection, hematoma, wound dehiscence and necrosis. [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Falu Lasarett — Falun

Публикации

• 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.
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07607366 · DNR-2025-00006-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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