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

NCT ID: NCT05272904

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-07-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional closure method

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.

Group Type: ACTIVE_COMPARATOR

Conventional wound closure

Intervention Type: PROCEDURE

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.

Quilting

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.

Group Type: EXPERIMENTAL

Quilting

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

OLVG

NETWORK

Sponsor Role: collaborator

Martini Hospital Groningen

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

St Jansdal Hospital

OTHER

Sponsor Role: collaborator

Bravis Hospital

OTHER

Sponsor Role: collaborator

Diakonessenhuis, Utrecht

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: collaborator

Gelderse Vallei Hospital

OTHER

Sponsor Role: collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lotte van Zeelst

Executive investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Central Contacts

Lotte van Zeelst, MS

Role: CONTACT

l.vanzeelst@cwz.nl

0031681515149

Luc Strobbe, PhD

Role: CONTACT

ljastrobbe@cwz.nl

References

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.

Reference Type: DERIVED

PMID: 41026907 (View on PubMed)

Other Identifiers

QUILT 2021-1

Identifier Type: -

Identifier Source: org_study_id