EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

NCT ID: NCT05509829

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-12-01

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.

Conditions

Breast Cancer; Seroma; Wound Complication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPWT group

Patients who receive NPWT after surgery.

Group Type: EXPERIMENTAL

Negative pressure wound therapy

Intervention Type: DEVICE

Negative pressure wound therapy using PICO14.

Control group

Retrospective cohort who did not receive NPWT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Negative pressure wound therapy

Negative pressure wound therapy using PICO14.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuyderland Medical Center

Sittard, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

James van Bastelaar, MD, PhD

Role: primary

j.vanbastelaar@zuyderland.nl

0031884597777

Merel Spiekerman van Weezelenburg, MD

Role: backup

m.spiekermanvanweezelenburg@zuyderland.nl

0031884597777

Other Identifiers

METCZ20220056

Identifier Type: -

Identifier Source: org_study_id