Clinical trial · Interventional
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional wound closure | Procedure | — | UNRESOLVED |
| Quilting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional closure method
- description
- 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.
- interventionNames
- Procedure: Conventional wound closure
- type
- EXPERIMENTAL
- label
- Quilting
- description
- 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.
- interventionNames
- Procedure: Quilting
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * patients who objected to participation (letter of objection) * mentally incompetent patients or otherwise unable to complete a questionnaire * immediate breast reconstruction * pregnancy
References
Publications (1)
- DERIVEDZeelst 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 41026907