EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

Study Overview
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Brief Summary
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Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction.Therefore, the aim of this trial is to evaluate the feasibility of NPWT after surgery and its effects on postoperative complications.

Detailed Description
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Rationale: Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. Complication rate after breast conserving surgery for breast cancer is 2-17%, surgical site infections (SSI) being the most common. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction. Therefore, in this trial, the aim is to evaluate the feasibility of NPWT after breast conserving surgery and its effects on postoperative complications. Objective and study parameters: Primary objective is to compare surgical site complications in patients with and without NPWT. Secondary objective is to assess the number of re-interventions, unplanned visits and pain scores. Study design: A prospective cohort of 150 patients will be compared to a retrospective cohort of 150 patients. Study population: Breast cancer patients undergoing breast conserving surgery with or without sentinel lymph node biopsy. Intervention (if applicable): Negative pressure wound therapy. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating in this study, patients will need to pay at least one extra visit to the hospital, possibly two if this cannot be combined with the standard postoperative visits. In addition, patients will need to have a device with them for 14 days after surgery. This device is connected to the wound dressing. All wound dressings may cause irritation or an allergic reaction. This risk is not higher than when receiving standard wound dressing, but it is something to take into consideration. Patients participating in this study may benefit from NPWT regarding the postoperative complication rate.

Official Title
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EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

Conditions
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Breast Cancer, Seroma, Wound Complication

Intervention / Treatment
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* Device: Negative pressure wound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eighteen years or older. Female sex. Indication for breast conserving surgery, with or without sentinel lymph node biopsy. Exclusion Criteria: Undergoing mastectomy or modified radical mastectomy. Undergoing direct breast reconstruction. Patients with a pacemaker, intra cardiac defibrillator (ICD) or other medical device in the proximity of the wound area, due to the magnet in the PICO® device. Unable to comprehend implications and extent of the study and/or unable to sign for informed consent. Participation in another breast cancer surgery related clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 150 patients of the prospectively included cohort will undergo NPWT. 150 patients of the retrospective cohort are used as a control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPWT group<br>Patients who receive NPWT after surgery. | Device: Negative pressure wound therapy<br>* Negative pressure wound therapy using PICO14.<br>|
| No Intervention: Control group<br>Retrospective cohort who did not receive NPWT. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of re-intervention | Number of patients who were in need of re-intervention(s) due to the previously mentioned surgical complications | 3 months after surgery | 
| Number of unscheduled visits to the emergency department or outpatient clinic | Number of unscheduled visits to the emergency department or outpatient clinic | 3 months after surgery | 
| Pain scores during NPWT | A numeric rating score will be asked to all patients receiving NPWT. | one week after surgery |