EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

Not Applicable

Recruiting

• Conditions: Seroma; Wound Complication; Breast Cancer
• Interventions: Device: Negative pressure wound therapy

• Registration Number: NCT05509829
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Status Verified: 2023-01
• Study Start: 2023-05-01
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPWT group	Negative pressure wound therapy	Patients who receive NPWT after surgery.

Primary Outcome Measures

Name	Time	Method
Surgical complications	3 months after surgery	Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zuyderland Medical Center; 🇳🇱 Sittard, Limburg, Netherlands