Clinical trial NCT05272904: The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery
Official title: The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma
Keywords: Mastectomy
Breast cancer surgery
Quilting
Flap fixation
Seroma
Complications
Shoulder function
Pain
Cosmetic outcome
Health care consumption
Lead sponsor: Canisius-Wilhelmina Hospital
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: OLVG
name: Martini Hospital Groningen
name: Catharina Ziekenhuis Eindhoven
name: St Jansdal Hospital
name: Bravis Hospital
name: Diakonessenhuis, Utrecht
name: St. Antonius Hospital
name: Gelderse Vallei Hospital
First posted: 2022-03-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The QUILT study is a stepped wedge cluster randomized study.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Textbook outcome
timeFrame: 6 months
Secondary outcomes:
measure: All palpation-detected seromas
timeFrame: 6 months
measure: Clinical significant seroma
timeFrame: 6 months
measure: Surgical site infections
timeFrame: 6 months
measure: Bleeding complications
timeFrame: 6 months
measure: Wound healing problems
timeFrame: 6 months
measure: Duration of surgery
timeFrame: 360 minutes
measure: Length of hospital stay
timeFrame: 6 months
measure: Unscheduled visits to the outpatient clinic
timeFrame: 6 months
measure: Readmission to the hospital
timeFrame: 6 months
measure: Reoperation
timeFrame: 6 months
measure: Shoulder function
timeFrame: 6 months
measure: Post-operative pain
timeFrame: 14 days
measure: Post-operative pain
timeFrame: 6 months
measure: Cosmetic outcome assessed by an independent panel
timeFrame: 6 months
measure: Patient reported satisfaction with breast
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
Study officials:
References: