EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery

NCT05509829 | Unknown DMC

• 1 other identifier: METCZ20220056
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Seroma; Wound Complication

Outcome Measures

Primary Outcomes (1)

• Surgical complications

  Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.

  3 months after surgery

Secondary Outcomes (3)

• Need of re-intervention

  3 months after surgery

• Number of unscheduled visits to the emergency department or outpatient clinic

  3 months after surgery

• Pain scores during NPWT

  one week after surgery

Study Arms (2)

NPWT group

EXPERIMENTAL

Patients who receive NPWT after surgery.

Device: Negative pressure wound therapy

Control group

NO INTERVENTION

Retrospective cohort who did not receive NPWT.

Interventions

Negative pressure wound therapy DEVICE

Negative pressure wound therapy using PICO14.

NPWT group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years or older.
• Female sex.
• Indication for breast conserving surgery, with or without sentinel lymph node biopsy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 150 patients of the prospectively included cohort will undergo NPWT. 150 patients of the retrospective cohort are used as a control group.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)