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

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.

Conditions

• Seroma

Interventions

PROCEDURE

Quilting

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.

PROCEDURE

Conventional wound closure

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.

Sponsors & Collaborators

• Rijnstate Hospital

  collaborator OTHER

• OLVG

  collaborator NETWORK

• Martini Hospital Groningen

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• St Jansdal Hospital

  collaborator OTHER

• Bravis Hospital

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Gelderse Vallei Hospital

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2023-01-01

Completion

2023-07-01

Countries

• Netherlands

Study Locations