Breast CancerSARANCT04035590
Seroma Reduction and Drain Free Mastectomy
A study testing No drain and With drain in people with Breast Cancer and Seroma, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications. 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?
- No drain and With drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2020to 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
- Older than 18 years
- Female sex
- Indication for mastectomy
Who cannot join
- Patients undergoing breast conserving therapy
- Patients undergoing modified radical mastectomy
- Patients undergoing direct breast reconstruction
- Unable to comprehend implications and extent of study and sign for informed consent
- Patients with radiation therapy of unilateral breast in previous history
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medisch Centrum
Sittard, Limburg, 6162 BG
James van Bastelaar, MD, +31641227350, j.vanbastelaar@zuyderland.nl
About this study
To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
Read the detailed description
Rationale:
Seroma formation, a collection of serous fluid containing blood plasma and/or lymph fluid, is a common complication in breast cancer surgery and can lead to delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the outpatient clinic and therefore extensive research has been done to further elucidate the pathophysiology and prevention of seroma formation. Promising results have resulted from studies focusing on flap fixation in order to reduce the incidence of seroma and seroma aspirations. Mastectomy with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. Closed-suction drainage is considered gold standard for reducing seroma formation after breast cancer surgery. However, evidence shows that closed-suction drainage is insufficient in preventing seroma formation. One might wonder if there is still a place for closed-suction drainage after mastectomy if flap fixation is performed. The promising results in flap fixation could exclude drainage systems in breast cancer surgery. However, the available data consist of small case series and therefore a large randomized controlled trial is needed for it to be widely implemented.
To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome.
The investigators hypothesize that flap fixation with closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to flap fixation alone. The investigators also expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.
Objective: To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
Study design: Prospective randomized controlled trial
Study population: Female patients > 18 years diagnosed with invasive breast cancer or DCIS (ductal carcinoma in situ) with an indication to perform mastectomy
Intervention (if applicable):
- Mastectomy with flap fixation using sutures with closed suction drainage
- Mastectomy with flap fixation using sutures without closed suction drainage
Main study parameters/endpoints:
Patients undergoing seroma aspiration (clinically significant seroma (CSS)).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at 2 weeks and 3 months. Additional study postoperative check-ups: 6 weeks, 6 months. Therefore, patients will be required to undergo two additional check-ups.
During out patients' visits, patients will hand in a questionnaire scale regarding cosmesis, pain and quality of life.
Patients will be clinically examined as they usually would be.
- Conditions
- Breast Cancer, Seroma, Wound Complication
- Being tested
- No drain, With drain
- Keywords
- Mastectomy, Drain
- 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.
No drainProcedure or surgery
Mastectomy with flap fixation without low vacuum drainage
With drainProcedure or surgery
Mastectomy with flap fixation with low vacuum drainage
| Study group | Role | What they receive |
|---|---|---|
| With drain | Active comparator | Patients undergo mastectomy with flap fixation and low vacuum drainage. Receives: Procedure: With drain |
| No drain | Experimental | Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted. Receives: Procedure: No drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma aspiration of clinically significant seroma
Proportion of patients undergoing seroma aspiration of clinically significant seroma
Clinically significant seroma defined as:
- Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis)
- There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin.
- There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
Measured: During first six months post-operative
Secondary outcomes (6)
Number of invasive interventions related to seroma or wound healing
Number of invasive interventions related to seroma or wound healing defined as: every aspiration of clinically significant seroma, incision and drainage of abscess or infected seroma and/or operative debriding of the wound.
Measured: During first six months post-operative
Surgical site infection (SSI) rate
Surgical site infection (SSI) rate, defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage.
Measured: During the first six postoperative months
Cosmesis
Cosmesis rated by the patient using the numeric rating scale (NRS) every planned outpatient clinic visit.
Measured: During the first six postoperative months
Quality of life measured using the SF-12 Health Survey
Quality of life measured using the SF-12 Health Survey. Resulting in 2 scores: the Mental Component Summary (MCS) and the Physical Component Summary (PCS). Both range between values of 0-100 with a score of 50 representing values of a standard population
Measured: During the first six postoperative months
The number of outpatient department visits
The number of outpatient department visits
Measured: During the first six months postoperative.
Experienced pain: NRS
Experienced wound pain and pain at the drain site by the patient using the NRS with a scale range from 0-10
Measured: During the first six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start26 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design is a randomized controlled trial. All patients are \> 18 years and will be enrolled after obtaining informed consent in the surgical out patient clinics of Zuyderland Medical Center Sittard. All patients have an indication to undergo mastectomy due to invasive breast cancer or DCIS. Follow up will be performed until 6 months after surgery. Patients will be evaluated in the out patient clinic 1 week, 6 weeks, 3 months and 6 months.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James van Bastelaar, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035590
- Sponsor's protocol ID
- METCZ2019016
- Acronym
- SARA
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. BMC Cancer. 2020 Aug 7;20(1):735. doi: 10.1186/s12885-020-07242-0.
PubMed 32767988
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
- Seroma Reduction and Drain Free Mastectomy
- ClinicalTrials.gov ID
- NCT04035590
- Acronym / sponsor ID
- SARA / METCZ2019016
- Conditions
- Breast Cancer, Seroma, Wound Complication
- Keywords
- Mastectomy, Drain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Jul 2019 (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.
To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
Detailed description
Rationale:
Seroma formation, a collection of serous fluid containing blood plasma and/or lymph fluid, is a common complication in breast cancer surgery and can lead to delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the outpatient clinic and therefore extensive research has been done to further elucidate the pathophysiology and prevention of seroma formation. Promising results have resulted from studies focusing on flap fixation in order to reduce the incidence of seroma and seroma aspirations. Mastectomy with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. Closed-suction drainage is considered gold standard for reducing seroma formation after breast cancer surgery. However, evidence shows that closed-suction drainage is insufficient in preventing seroma formation. One might wonder if there is still a place for closed-suction drainage after mastectomy if flap fixation is performed. The promising results in flap fixation could exclude drainage systems in breast cancer surgery. However, the available data consist of small case series and therefore a large randomized controlled trial is needed for it to be widely implemented.
To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome.
The investigators hypothesize that flap fixation with closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to flap fixation alone. The investigators also expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.
Objective: To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
Study design: Prospective randomized controlled trial
Study population: Female patients > 18 years diagnosed with invasive breast cancer or DCIS (ductal carcinoma in situ) with an indication to perform mastectomy
Intervention (if applicable):
- Mastectomy with flap fixation using sutures with closed suction drainage
- Mastectomy with flap fixation using sutures without closed suction drainage
Main study parameters/endpoints:
Patients undergoing seroma aspiration (clinically significant seroma (CSS)).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at 2 weeks and 3 months. Additional study postoperative check-ups: 6 weeks, 6 months. Therefore, patients will be required to undergo two additional check-ups.
During out patients' visits, patients will hand in a questionnaire scale regarding cosmesis, pain and quality of life.
Patients will be clinically examined as they usually would be.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design is a randomized controlled trial. All patients are > 18 years and will be enrolled after obtaining informed consent in the surgical out patient clinics of Zuyderland Medical Center Sittard. All patients have an indication to undergo mastectomy due to invasive breast cancer or DCIS. Follow up will be performed until 6 months after surgery. Patients will be evaluated in the out patient clinic 1 week, 6 weeks, 3 months and 6 months.
| Arm | Type | Receives |
|---|---|---|
| With drain | Active comparator | Procedure: With drainPatients undergo mastectomy with flap fixation and low vacuum drainage. |
| No drain | Experimental | Procedure: No drainPatients undergo mastectomy with flap fixation and low vacuum drainage is omitted. |
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)
- Older than 18 years
- Female sex
- Indication for mastectomy
Key exclusion criteria (5 listed)
- Patients undergoing breast conserving therapy
- Patients undergoing modified radical mastectomy
- Patients undergoing direct breast reconstruction
- Unable to comprehend implications and extent of study and sign for informed consent
- Patients with radiation therapy of unilateral breast in previous history
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 |
|---|---|---|
| No drainMastectomy with flap fixation without low vacuum drainage | Procedure or surgery | No drain |
| With drainMastectomy with flap fixation with low vacuum drainage | Procedure or surgery | With drain |
Primary outcome
Seroma aspiration of clinically significant seroma
Time frame: During first six months post-operative
Proportion of patients undergoing seroma aspiration of clinically significant seroma Clinically significant seroma defined as: 1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) 2. There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin. 3. There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
6 secondary outcomes
Number of invasive interventions related to seroma or wound healing
Time frame: During first six months post-operative
Surgical site infection (SSI) rate
Time frame: During the first six postoperative months
Cosmesis
Time frame: During the first six postoperative months
Quality of life measured using the SF-12 Health Survey
Time frame: During the first six postoperative months
The number of outpatient department visits
Time frame: During the first six months postoperative.
Experienced pain: NRS
Time frame: During the first six months postoperative
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.
- Derived from this study: PubMed 32767988de Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. BMC Cancer. 2020 Aug 7;20(1):735. doi: 10.1186/s12885-020-07242-0.
- 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 No drain and With drain 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?
Contact James van Bastelaar, MD, PhD (+31884591870, j.vanbastelaar@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma aspiration of clinically significant seroma (time frame: During first six months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035590, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 1 Nov 2026.