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

The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Seroma
• Intervention / Treatment: Procedure: Conventional wound closure; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 113
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotte van Zeelst, MS; Phone Number: 0031681515149; Email: l.vanzeelst@cwz.nl
• Study Contact Backup: Name: Luc Strobbe, PhD; Email: ljastrobbe@cwz.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius Wilhelmina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All palpation-detected seromas	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Clinical significant seroma	All aspirated seroma. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Surgical site infections	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Bleeding complications	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Wound healing problems	Including skin flap necrosis, wound necrosis, wound dehiscence. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Duration of surgery	Duration of surgery in minutes.	360 minutes
Length of hospital stay	Length of hospital stay in days: distinguishing between outpatient and inpatient treatment.	6 months
Unscheduled visits to the outpatient clinic	Number of unscheduled visits to the outpatient clinic	6 months
Readmission to the hospital	Readmission to the hospital related to primary surgery	6 months
Reoperation	Reoperation related to primary surgery other than re-excision.	6 months
Shoulder function	Assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Higher scores mean a worse outcome.	6 months
Post-operative pain	Assessed using the visual analogue scale (VAS). Scale 1-10, higher scores mean a worse outcome.	14 days
Post-operative pain	Post-operative use of analgesics (paracetamol, NSAID's, opioids).	6 months
Cosmetic outcome assessed by an independent panel	an independent panel of four surgeons will blindly assess cosmetics by classifying standardised digital photographs one a 4-point Likert scale with the following categories: poor, fair, good and excellent. Photos are taken in two positions: the first in neutral position with both arms hanging next to the body and the second with both arms raised in 180gr (or as far as possible) elevation.	6 months
Patient reported satisfaction with breast	BreastQ questionnaire for mastectomy	6 months

Collaborators and Investigators

• Sponsor: Canisius-Wilhelmina Hospital
• Collaborators: Catharina Ziekenhuis Eindhoven; St. Antonius Hospital; Rijnstate Hospital; Diakonessenhuis, Utrecht; OLVG; Martini Hospital Groningen; St Jansdal Hospital; Bravis Hospital; Gelderse Vallei Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Complications; Mastectomy; Seroma; Shoulder function; Cosmetic outcome; Breast cancer surgery; Quilting; Flap fixation; Health care consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: QUILT 2021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No