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Trial Title:
EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
NCT ID:
NCT05509829
Condition:
Breast Cancer
Seroma
Wound Complication
Conditions: Official terms:
Seroma
Wounds and Injuries
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Negative pressure wound therapy
Description:
Negative pressure wound therapy using PICO14.
Arm group label:
NPWT group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuyderland Medical Center
Address:
City:
Sittard
Zip:
6162BG
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
James van Bastelaar, MD, PhD
Phone:
0031884597777
Email:
j.vanbastelaar@zuyderland.nl
Contact backup:
Last name:
Merel Spiekerman van Weezelenburg, MD
Phone:
0031884597777
Email:
m.spiekermanvanweezelenburg@zuyderland.nl
Start date:
May 1, 2023
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Zuyderland Medisch Centrum
Agency class:
Other
Source:
Zuyderland Medisch Centrum
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05509829
