NCT05272904

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

December 30, 2021

Last Update Submit

March 8, 2022

Conditions

Seroma

Keywords

MastectomyBreast cancer surgeryQuiltingFlap fixationSeromaComplicationsShoulder functionPainCosmetic outcomeHealth care consumption

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (15)

  • All palpation-detected seromas

    6 months

  • Clinical significant seroma

    6 months

  • Surgical site infections

    6 months

  • Bleeding complications

    6 months

  • Wound healing problems

    6 months

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Quilting

Interventions

QuiltingPROCEDURE

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.

Quilting
Conventional wound closurePROCEDURE

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.

Conventional closure method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients who objected to participation (letter of objection)
  • mentally incompetent patients or otherwise unable to complete a questionnaire
  • immediate breast reconstruction
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 41026907DERIVED

MeSH Terms

Conditions

SeromaPain

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Lotte van Zeelst, MS

CONTACT

0031681515149l.vanzeelst@cwz.nl

Luc Strobbe, PhD

CONTACT

ljastrobbe@cwz.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Surgical technique is not blinded for surgeon and/or patients. An independent panel of four surgeons will blindly assess cosmetics.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The QUILT study is a stepped wedge cluster randomized study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive investigator

Study Record Dates

First Submitted

December 30, 2021

First Posted

March 10, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.

Shared Documents
STUDY PROTOCOL

Locations

NL(1)