Clinical trial · Interventional
EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
NCT05509829CI-TRIAL-00067862LAURENunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Seroma | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative pressure wound therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NPWT group
- description
- Patients who receive NPWT after surgery.
- interventionNames
- Device: Negative pressure wound therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- Retrospective cohort who did not receive NPWT.
Primary outcomes (1)
- measure
- Surgical complications
- timeFrame
- 3 months after surgery
- description
- Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.