EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery (LAUREN)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Seroma; Wound Complication
• Intervention / Treatment: Device: Negative pressure wound therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162BG
      • Recruiting
      • Zuyderland Medical Center
      • Contact: James van Bastelaar, MD, PhD; Phone Number: 0031884597777; Email: j.vanbastelaar@zuyderland.nl
      • Contact: Merel Spiekerman van Weezelenburg, MD; Phone Number: 0031884597777; Email: m.spiekermanvanweezelenburg@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Wounds and Injuries; Seroma
• Other Study ID Numbers: METCZ20220056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No