EvaLuating negAtive pressUre wound theRapy in brEast coNserving surgery - the LAUREN pilot study

EvaLuating negAtive pressUre wound theRapy in brEast coNserving surgery - the LAUREN pilot study - LAUREN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53621

Enrollment

300

Registered

2022-07-25

Start date

2023-06-16

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammacarcinoma

Interventions

Negative pressure wound therapy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Eighteen years or older. - Female sex. - Indication for breast conserving surgery, with or without sentinel lymph node biopsy

Exclusion criteria

Exclusion criteria: - Undergoing mastectomy or modified radical mastectomy. - Undergoing direct breast reconstruction. - Patients with a pacemaker, 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.

Design outcomes

Primary

Measure	Time frame
Number of patients with postoperative wound complications during the first three months after surgery. Wound complications include: o clinically significant seroma. This is defined as seroma which: a) compromises wound healing, b) causes significant pain or discomfort or c) is contaminated, and requires intervention (aspiration, surgical debridement). o surgical site infections requiring oral or intravenous antibiotic treatment or surgical intervention(s). o wound dehiscence as defined by the World Union of Wound Healing Societies: separation of the margins of a closed surgical incision that has been made in skin, with or without exposure or protrusion of underlying tissue, organs or implants. Separation may occur at single or multiple regions, or involve the full length of the incision and may affect some or all tissue layers. o wound necrosis requiring surgical intervention(s). o hematoma requiring surgical intervention(s).	—

Measure

Time frame

Number of patients with postoperative wound complications during the first three months after surgery. Wound complications include: o clinically significant seroma. This is defined as seroma which: a) compromises wound healing, b) causes significant pain or discomfort or c) is contaminated, and requires intervention (aspiration, surgical debridement). o surgical site infections requiring oral or intravenous antibiotic treatment or surgical intervention(s). o wound dehiscence as defined by the World Union of Wound Healing Societies: separation of the margins of a closed surgical incision that has been made in skin, with or without exposure or protrusion of underlying tissue, organs or implants. Separation may occur at single or multiple regions, or involve the full length of the incision and may affect some or all tissue layers. o wound necrosis requiring surgical intervention(s). o hematoma requiring surgical intervention(s).

—

Secondary

Measure	Time frame
- Pain scores during NPWT. This will be assessed using a visual analogue scale (VAS) ranging from 0-10. - Burden for patients, which will be measured in two ways: EQ-5D-5L questionnaire and patient interviews in the first 20 patients - Number of unplanned outpatient clinic visits or phone calls. - Number of re-interventions.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026