SeromaQUILTNCT05272904
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery
A study testing Quilting and Conventional wound closure in people with Seroma, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
Trial summary
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seroma
- What is being tested?
- Quilting and Conventional wound closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 1 Jul 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients >18 years of age undergoing mastectomy and/or axillary lymph node dissection
- be irrespective of the nature of the primary tumour: prophylactic, risk reducing, benign, in situ carcinoma and invasive primary or recurrent carcinoma will be eligible, irrespective of preoperative systemic therapy.
Who cannot join
- patients who objected to participation (letter of objection)
- mentally incompetent patients or otherwise unable to complete a questionnaire
- immediate breast reconstruction
- pregnancy
Trial locations and contacts
1 site in 1 country.
Luc Strobbe, PhD contact
Netherlands1 site
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532 SZ
About this study
Official title: The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. Main objective of this randomized stepped wedge study is to assess the impact of large scale implementation of the quilting technique in patients undergoing mastectomy and/or axillary lymph node dissection. This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple and cost-effective technique to increase textbook outcome. Moreover, it is expected that patient comfort is enhanced by quilting.
Read the detailed description
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).
The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and use of analgesics is not increased postoperative. A total of 113 patients is required based on a sample size calculation.
This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple technique to increase textbook outcome, without increasing health care consumption. Moreover, the expectation is that patient comfort is enhanced by quilting.
- Conditions
- Seroma
- Being tested
- Quilting, Conventional wound closure
- Keywords
- Mastectomy, Breast cancer surgery, Quilting, Flap fixation, Seroma, Complications, Shoulder function, Pain, Cosmetic outcome, Health care consumption
- Medical subject headings
- Seroma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuiltingProcedure or surgery
Following mastectomy and/or axillary lymph node dissection, the subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to five rows for the cranial flap. The caudal flap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin.
Conventional wound closureProcedure or surgery
Following mastectomy, skin is closed using subcutaneous sutures followed by intracutaneous running suture. Depending on the surgeons discretion a vacuum closed suction drain was placed beneath the skin flaps.
| Study group | Role | What they receive |
|---|---|---|
| Conventional closure method | Active comparator | Following mastectomy, skin is closed using subcutaneous sutures followed by intracutaneous running suture. Depending on the surgeons discretion a vacuum closed suction drain was placed beneath the skin flaps. Receives: Procedure: Conventional wound closure |
| Quilting | Experimental | The implemented intervention is the quilting suture technique. The subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to five rows for the cranial flap. The caudal flap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin. No wound drain is placed. Receives: Procedure: Quilting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook outcome
'Textbook outcome' (TO), a combination of outcome parameters reflecting an ideal surgical outcome. Measured 6 months post-operative, the patients postoperative course must comply with the following to meet the definition of TO:
- no wound complications
- no re-admissions in relation to primary surgery
- no re-operation in relation to primary surgery, re-excisions in case of involved margins allowed
- no unscheduled visit to the outpatient clinic (depending on the centre one or two postoperative visits are usually scheduled)
- postoperative use of analgesics (6 months) is not increased compared to pre-operative
Measured: 6 months
Secondary outcomes (15)
All palpation-detected seromas
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Measured: 6 months
Clinical significant seroma
All aspirated seroma. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Measured: 6 months
Surgical site infections
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Measured: 6 months
Bleeding complications
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Measured: 6 months
Wound healing problems
Including skin flap necrosis, wound necrosis, wound dehiscence. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Measured: 6 months
Duration of surgery
Duration of surgery in minutes.
Measured: 360 minutes
Length of hospital stay
Length of hospital stay in days: distinguishing between outpatient and inpatient treatment.
Measured: 6 months
Unscheduled visits to the outpatient clinic
Number of unscheduled visits to the outpatient clinic
Measured: 6 months
Readmission to the hospital
Readmission to the hospital related to primary surgery
Measured: 6 months
Reoperation
Reoperation related to primary surgery other than re-excision.
Measured: 6 months
Shoulder function
Assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Higher scores mean a worse outcome.
Measured: 6 months
Post-operative pain
Assessed using the visual analogue scale (VAS). Scale 1-10, higher scores mean a worse outcome.
Measured: 14 days
Post-operative pain
Post-operative use of analgesics (paracetamol, NSAID's, opioids).
Measured: 6 months
Cosmetic outcome assessed by an independent panel
an independent panel of four surgeons will blindly assess cosmetics by classifying standardised digital photographs one a 4-point Likert scale with the following categories: poor, fair, good and excellent. Photos are taken in two positions: the first in neutral position with both arms hanging next to the body and the second with both arms raised in 180gr (or as far as possible) elevation.
Measured: 6 months
Patient reported satisfaction with breast
BreastQ questionnaire for mastectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 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 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
- Model description
- The QUILT study is a stepped wedge cluster randomized study.
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, OLVG, Martini Hospital Groningen, Catharina Ziekenhuis Eindhoven, St Jansdal Hospital, Bravis Hospital, Diakonessenhuis, Utrecht, St. Antonius Hospital, Gelderse Vallei Hospital
- Responsible party
- Principal investigator, Lotte van Zeelst, Canisius-Wilhelmina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272904
- Sponsor's protocol ID
- QUILT 2021-1
- Acronym
- QUILT
- Status last verified
- Mar 2022
- First submitted
- 30 Dec 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.
Publications
Zeelst LJV, Plate JDJ, van Eekeren RRJP, Ten Wolde B, Kroeze EMA, Schalken EC, de Wilt JHW, Strobbe LJA. Quilt technique after mastectomy: stepped-wedge randomized cluster trial showing superior textbook outcome and reduced healthcare utilization. Br J Surg. 2025 Sep 2;112(9):znaf175. doi: 10.1093/bjs/znaf175.
PubMed 41026907
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study
- ClinicalTrials.gov ID
- NCT05272904
- Acronym / sponsor ID
- QUILT / QUILT 2021-1
- Conditions
- Seroma
- Keywords
- Mastectomy, Breast cancer surgery, Quilting, Flap fixation, Seroma, Complications, Shoulder function, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, OLVG, Martini Hospital Groningen, Catharina Ziekenhuis Eindhoven, St Jansdal Hospital, Bravis Hospital, Diakonessenhuis, Utrecht, St. Antonius Hospital, Gelderse Vallei Hospital
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 10 Mar 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.
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. Main objective of this randomized stepped wedge study is to assess the impact of large scale implementation of the quilting technique in patients undergoing mastectomy and/or axillary lymph node dissection. This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple and cost-effective technique to increase textbook outcome. Moreover, it is expected that patient comfort is enhanced by quilting.
Detailed description
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).
The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and use of analgesics is not increased postoperative. A total of 113 patients is required based on a sample size calculation.
This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple technique to increase textbook outcome, without increasing health care consumption. Moreover, the expectation is that patient comfort is enhanced by quilting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The QUILT study is a stepped wedge cluster randomized study.
| Arm | Type | Receives |
|---|---|---|
| Conventional closure method | Active comparator | Procedure: Conventional wound closureFollowing mastectomy, skin is closed using subcutaneous sutures followed by intracutaneous running suture. Depending on the surgeons discretion a vacuum closed suction drain was placed beneath the skin flaps. |
| Quilting | Experimental | Procedure: QuiltingThe implemented intervention is the quilting suture technique. The subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to five rows for the cranial flap. The caudal flap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin. No wound drain is placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients >18 years of age undergoing mastectomy and/or axillary lymph node dissection
- be irrespective of the nature of the primary tumour: prophylactic, risk reducing, benign, in situ carcinoma and invasive primary or recurrent carcinoma will be eligible, irrespective of preoperative systemic therapy.
Key exclusion criteria (4 listed)
- patients who objected to participation (letter of objection)
- mentally incompetent patients or otherwise unable to complete a questionnaire
- immediate breast reconstruction
- pregnancy
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 |
|---|---|---|
| QuiltingFollowing mastectomy and/or axillary lymph node dissection, the subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to five rows for the cranial flap. The caudal flap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin. | Procedure or surgery | Quilting |
| Conventional wound closureFollowing mastectomy, skin is closed using subcutaneous sutures followed by intracutaneous running suture. Depending on the surgeons discretion a vacuum closed suction drain was placed beneath the skin flaps. | Procedure or surgery | Conventional closure method |
Primary outcome
Textbook outcome
Time frame: 6 months
'Textbook outcome' (TO), a combination of outcome parameters reflecting an ideal surgical outcome. Measured 6 months post-operative, the patients postoperative course must comply with the following to meet the definition of TO: * no wound complications * no re-admissions in relation to primary surgery * no re-operation in relation to primary surgery, re-excisions in case of involved margins allowed * no unscheduled visit to the outpatient clinic (depending on the centre one or two postoperative visits are usually scheduled) * postoperative use of analgesics (6 months) is not increased compared to pre-operative
15 secondary outcomes
All palpation-detected seromas
Time frame: 6 months
Clinical significant seroma
Time frame: 6 months
Surgical site infections
Time frame: 6 months
Bleeding complications
Time frame: 6 months
Wound healing problems
Time frame: 6 months
Duration of surgery
Time frame: 360 minutes
Length of hospital stay
Time frame: 6 months
Unscheduled visits to the outpatient clinic
Time frame: 6 months
Readmission to the hospital
Time frame: 6 months
Reoperation
Time frame: 6 months
Shoulder function
Time frame: 6 months
Post-operative pain
Time frame: 14 days
Post-operative pain
Time frame: 6 months
Cosmetic outcome assessed by an independent panel
Time frame: 6 months
Patient reported satisfaction with breast
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 41026907Zeelst LJV, Plate JDJ, van Eekeren RRJP, Ten Wolde B, Kroeze EMA, Schalken EC, de Wilt JHW, Strobbe LJA. Quilt technique after mastectomy: stepped-wedge randomized cluster trial showing superior textbook outcome and reduced healthcare utilization. Br J Surg. 2025 Sep 2;112(9):znaf175. doi: 10.1093/bjs/znaf175.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.
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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.
Luc Strobbe, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quilting and Conventional wound closure in people with Seroma, run by Canisius-Wilhelmina Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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 Lotte van Zeelst, MS (0031681515149, l.vanzeelst@cwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textbook outcome (time frame: 6 months). 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 NCT05272904, 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 10 Mar 2022.