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

Seroma Clinical Trial

— QUILT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05272904
• Other study ID #: QUILT 2021-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2022
• Source: Canisius-Wilhelmina Hospital
• Contact: Lotte van Zeelst, MS
• Phone: 0031681515149
• Email: l.vanzeelst[@]cwz.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 113
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Seroma

Intervention

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 ?ve rows for the cranial ?ap. The caudal ?ap 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland

Sponsors (10)

Lead Sponsor	Collaborator
Canisius-Wilhelmina Hospital	Bravis Hospital, Catharina Ziekenhuis Eindhoven, Diakonessenhuis, Utrecht, Gelderse Vallei Hospital, Martini Hospital Groningen, OLVG, Rijnstate Hospital, St Jansdal Hospital, St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All palpation-detected seromas	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Secondary	Clinical significant seroma	All aspirated seroma. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Secondary	Surgical site infections	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Secondary	Bleeding complications	Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).	6 months
Secondary	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
Secondary	Duration of surgery	Duration of surgery in minutes.	360 minutes
Secondary	Length of hospital stay	Length of hospital stay in days: distinguishing between outpatient and inpatient treatment.	6 months
Secondary	Unscheduled visits to the outpatient clinic	Number of unscheduled visits to the outpatient clinic	6 months
Secondary	Readmission to the hospital	Readmission to the hospital related to primary surgery	6 months
Secondary	Reoperation	Reoperation related to primary surgery other than re-excision.	6 months
Secondary	Shoulder function	Assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Higher scores mean a worse outcome.	6 months
Secondary	Post-operative pain	Assessed using the visual analogue scale (VAS). Scale 1-10, higher scores mean a worse outcome.	14 days
Secondary	Post-operative pain	Post-operative use of analgesics (paracetamol, NSAID's, opioids).	6 months
Secondary	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
Secondary	Patient reported satisfaction with breast	BreastQ questionnaire for mastectomy	6 months