Breast CancerLAURENNCT05509829
EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
A study testing Negative pressure wound therapy in people with Breast Cancer and Seroma, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Seroma, Wound Complication
- What is being tested?
- Negative pressure wound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years or older.
- Female sex.
- Indication for breast conserving surgery, with or without sentinel lymph node biopsy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medical Center
Sittard, Limburg, 6162BG
James van Bastelaar, MD, PhD, 0031884597777, j.vanbastelaar@zuyderland.nl
Merel Spiekerman van Weezelenburg, MD, 0031884597777, m.spiekermanvanweezelenburg@zuyderland.nl
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Seroma, Wound Complication
- Being tested
- Negative pressure wound therapy
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyDevice
Negative pressure wound therapy using PICO14.
| Study group | Role | What they receive |
|---|---|---|
| NPWT group | Experimental | Patients who receive NPWT after surgery. Receives: Device: Negative pressure wound therapy |
| Control group | No intervention | Retrospective cohort who did not receive NPWT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications
Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.
Measured: 3 months after surgery
Secondary outcomes (3)
Need of re-intervention
Number of patients who were in need of re-intervention(s) due to the previously mentioned surgical complications
Measured: 3 months after surgery
Number of unscheduled visits to the emergency department or outpatient clinic
Number of unscheduled visits to the emergency department or outpatient clinic
Measured: 3 months after surgery
Pain scores during NPWT
A numeric rating score will be asked to all patients receiving NPWT.
Measured: one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 May 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 150 patients of the prospectively included cohort will undergo NPWT. 150 patients of the retrospective cohort are used as a control group.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509829
- Sponsor's protocol ID
- METCZ20220056
- Acronym
- LAUREN
- Status last verified
- Jan 2023
- First submitted
- 18 Aug 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
- ClinicalTrials.gov ID
- NCT05509829
- Acronym / sponsor ID
- LAUREN / METCZ20220056
- Conditions
- Breast Cancer, Seroma, Wound Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 150 patients of the prospectively included cohort will undergo NPWT. 150 patients of the retrospective cohort are used as a control group.
| Arm | Type | Receives |
|---|---|---|
| NPWT group | Experimental | Device: Negative pressure wound therapyPatients who receive NPWT after surgery. |
| Control group | No intervention | –Retrospective cohort who did not receive NPWT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eighteen years or older.
- Female sex.
- Indication for breast conserving surgery, with or without sentinel lymph node biopsy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure wound therapyNegative pressure wound therapy using PICO14. | Device | NPWT group |
Primary outcome
Surgical complications
Time frame: 3 months after surgery
Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.
3 secondary outcomes
Need of re-intervention
Time frame: 3 months after surgery
Number of unscheduled visits to the emergency department or outpatient clinic
Time frame: 3 months after surgery
Pain scores during NPWT
Time frame: one week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy in people with Breast Cancer and Seroma, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complications (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.