The primary objective of this trial is to compare the number of postoperative wound complications in patients with and without negative pressure therapy after breast conserving surgery in the first three months after surgery. Wound complications…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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.
Background summary
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.
Study objective
The primary objective of this trial is to compare the number of postoperative
wound complications in patients with and without negative pressure therapy
after breast conserving surgery in the first three months after surgery. Wound
complications include clinical significant seroma, surgical site infections,
wound dehiscence or wound necrosis.
Secondary, in this trial the following secondary objectives will be assessed:
1. Pain scores
2. Burden for patients
3. Number of unplanned outpatient clinic visits or phone calls
4. Number of re-interventions
Study design
A prospective cohort of 150 patients will be compared to a retrospective cohort
of 150 patients.
Intervention
Negative pressure wound therapy
Study burden and risks
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.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
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, 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81779.096.22 |