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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Seroma

Intervention / Treatment
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* Procedure: Quilting
* Procedure: Conventional wound closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The QUILT study is a stepped wedge cluster randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional closure method<br>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<br>* 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.<br>|
| Experimental: Quilting<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastectomy, Breast cancer surgery, Quilting, Flap fixation, Seroma, Complications, Shoulder function, Pain, Cosmetic outcome, Health care consumption