SeromaANNIENCT05941351
fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma
A study testing flap fixation in people with Seroma, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Seroma
- What is being tested?
- flap fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female sex.
- 18 years or older.
- Indication for mastectomy.
Who cannot join
- Patients undergoing breast conserving therapy
- Patients undergoing direct breast reconstruction
- Patients undergoing modified radical mastectomy
- Unable to comprehend implications and extent of study and sign for informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Zuyderland MC
Sittard, Limbrug, 6162BG
Merel Spiekerman van Weezelenburg, MD, +31884597777, m.spiekermanvanweezelenburg@zuyderland.nl
About this study
Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. A recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking.
Objective: This prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy.
Read more
Study design: This trial will combine a retrospective cohort from the previous SARA-trial in Zuyderland MC with a randomised prospective trial. This study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame.
Study population: A retrospective cohort of patients participating in the SARA trial (RCT) and a prospective cohort of patients undergoing a mastectomy for breast cancer.
Intervention: Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.
Main study parameters/endpoints: The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. Secondarily, the length of the procedure and cosmetic results will be compared.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating, patients will undergo 3 additional outpatient clinic visits. Study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.
- Conditions
- Seroma
- Being tested
- flap fixation
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap fixationProcedure or surgery
flap fixation using running or interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| Running | Other | Group 1: Flap fixation after mastectomy with running sutures. Receives: Procedure: flap fixation |
| Individual | Other | Group 2: Flap fixation after mastectomy with interrupted sutures. Receives: Procedure: flap fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications requiring an intervention
The main study parameter is the incidence of complications requiring interventions in both groups. This consists of:
- Clinically significant seroma, requiring aspirations in the case of:
- Pain or discomfort for the patient caused by large amounts of seroma characterised by tenderness of the skin.
- Signs of infection (redness, swelling, pain).
- Signs of delayed wound healing (wound breakdown, necrosis, seroma leakage).
- Surgical site infections, requiring oral/iv antibiotics or surgical drainage.
- Bleeding complications, requiring re-intervention, aspiration or surgical debridement.
Measured: 3 months
Secondary outcomes (2)
Surgery time
surgery time in minutes
Measured: during surgery
Cosmetic outcome
- Cosmetic results measured using a numeric rating score (NRS) from 0-10, in which 0 equals very dissatisfied with the cosmetic results and 10 equals very satisfied with the results.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 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
- NCT05941351
- Sponsor's protocol ID
- METCZ20230049
- Acronym
- ANNIE
- Status last verified
- Jun 2023
- First submitted
- 3 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma
- ClinicalTrials.gov ID
- NCT05941351
- Acronym / sponsor ID
- ANNIE / METCZ20230049
- Conditions
- Seroma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 361 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Jul 2023 (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.
Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. A recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking.
Objective: This prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy.
Study design: This trial will combine a retrospective cohort from the previous SARA-trial in Zuyderland MC with a randomised prospective trial. This study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame.
Study population: A retrospective cohort of patients participating in the SARA trial (RCT) and a prospective cohort of patients undergoing a mastectomy for breast cancer.
Intervention: Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.
Main study parameters/endpoints: The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. Secondarily, the length of the procedure and cosmetic results will be compared.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating, patients will undergo 3 additional outpatient clinic visits. Study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Running | Other | Procedure: flap fixationGroup 1: Flap fixation after mastectomy with running sutures. |
| Individual | Other | Procedure: flap fixationGroup 2: Flap fixation after mastectomy with interrupted sutures. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female sex.
- 18 years or older.
- Indication for mastectomy.
Key exclusion criteria (4 listed)
- Patients undergoing breast conserving therapy
- Patients undergoing direct breast reconstruction
- Patients undergoing modified radical mastectomy
- Unable to comprehend implications and extent of study and sign for informed consent
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 |
|---|---|---|
| flap fixationflap fixation using running or interrupted sutures | Procedure or surgery | Individual, Running |
Primary outcome
Complications requiring an intervention
Time frame: 3 months
The main study parameter is the incidence of complications requiring interventions in both groups. This consists of: * Clinically significant seroma, requiring aspirations in the case of: * Pain or discomfort for the patient caused by large amounts of seroma characterised by tenderness of the skin. * Signs of infection (redness, swelling, pain). * Signs of delayed wound healing (wound breakdown, necrosis, seroma leakage). * Surgical site infections, requiring oral/iv antibiotics or surgical drainage. * Bleeding complications, requiring re-intervention, aspiration or surgical debridement.
2 secondary outcomes
Surgery time
Time frame: during surgery
Cosmetic outcome
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flap fixation in people with 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 4 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: opening soon, as of the sponsor's last update on 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel Spiekerman van Weezelenburg, MD (+31884597777, m.spiekermanvanweezelenburg@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications requiring an intervention (time frame: 3 months). 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 12 Jul 2023.