Clinical trial NCT05509829: EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
Official title: EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Seroma
Wound Complication
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 150 patients of the prospectively included cohort will undergo NPWT. 150 patients of the retrospective cohort are used as a control group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgical complications
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Need of re-intervention
timeFrame: 3 months after surgery
measure: Number of unscheduled visits to the emergency department or outpatient clinic
timeFrame: 3 months after surgery
measure: Pain scores during NPWT
timeFrame: one week after surgery
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
References: