UnknownNot Applicable

EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

Netherlands300 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical complications

Timeframe: 3 months after surgery

Trial details

NCT IDNCT05509829

SponsorZuyderland Medisch Centrum

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

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