An interventional study of Quilting and Conventional wound closure in Seroma, sponsored by Canisius-Wilhelmina Hospital. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Canisius-Wilhelmina Hospital · Not applicable, Interventional, and Prevention
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.
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 113 is above the median of 100 across 92 interventional studies indexed under Seroma.
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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
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.
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.
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
Time frame: 6 months
All palpation-detected seromas
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Time frame: 6 months
Clinical significant seroma
All aspirated seroma. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Time frame: 6 months
Surgical site infections
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Time frame: 6 months
Bleeding complications
Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).
Time frame: 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).
Time frame: 6 months
Duration of surgery
Duration of surgery in minutes.
Time frame: 360 minutes
Length of hospital stay
Length of hospital stay in days: distinguishing between outpatient and inpatient treatment.
Time frame: 6 months
Unscheduled visits to the outpatient clinic
Number of unscheduled visits to the outpatient clinic
Time frame: 6 months
Readmission to the hospital
Readmission to the hospital related to primary surgery
Time frame: 6 months
Reoperation
Reoperation related to primary surgery other than re-excision.
Time frame: 6 months
Shoulder function
Assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Higher scores mean a worse outcome.
Time frame: 6 months
Post-operative pain
Assessed using the visual analogue scale (VAS). Scale 1-10, higher scores mean a worse outcome.
Time frame: 14 days
Post-operative pain
Post-operative use of analgesics (paracetamol, NSAID's, opioids).
Time frame: 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.
Time frame: 6 months
Patient reported satisfaction with breast
BreastQ questionnaire for mastectomy
Time frame: 6 months
Plan to share: Yes — The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.
Supporting information: Study protocol
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Canisius-Wilhelmina Hospital