NCT05272904: QUILT

The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery

Status unknown NA Last updated 10 March 2022

What this trial tests

NA trial testing Quilting in Seroma in 113 participants. Status unknown.

Timeline

1 August 2022

Primary endpoint
1 January 2023

1 July 2023

Quick facts

Lead sponsor	Canisius-Wilhelmina Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	113
Start date	1 August 2022
Primary completion	1 January 2023
Estimated completion	1 July 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Quilting
• Conventional wound closure

Conditions studied

• Seroma — all drugs for Seroma →

Sponsor

Canisius-Wilhelmina Hospital

Who can join

18 and older, any sex, with Seroma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current use of drains and management of seroma following mastectomy and axillary surgery: results of a United Kingdom national practice survey.
   Fairhurst K, Roberts K, Fairbrother P, Potter S, et al · · 2024 · cited 6× · PMID 37878150 · DOI 10.1007/s10549-023-07042-7
2. Quilt technique after mastectomy: stepped-wedge randomized cluster trial showing superior textbook outcome and reduced healthcare utilization.
   Zeelst LJV, Plate JDJ, van Eekeren RRJP, Ten Wolde B, et al · · 2025 · PMID 41026907 · DOI 10.1093/bjs/znaf175