Clinical trial NCT03902977: Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection
Official title: Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection in Patients With Breast Cancer: a Single Blind Randomised Phase III Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Lindenhofgruppe AG
Sponsor class: INDUSTRY
Collaborators: name: University of Bern
name: StiftungLindenhof
First posted: 2019-04-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients have undergone surgery for treatment of breast cancer. During surgery they are assigned to one of two groups (randomization 1:1): quilting or conventional suture.
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalization. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs, providing the rationale for this study.The aim of our project is to compare the efficacy of quilting suture with that of conventional closure without quilting in reducing the drainage quantity, the length of hospitalisation and the prevalence of seroma following mastectomy and/or axilla for breast cancer, as well as the patient reported pain increasing patient quality of life.

The final goal is the omission of axillary drainage in the future. All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (EQ5-D: European Quality of Life and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

Total duration of study: 2.5 years. There are 2 treatments groups 50% of the study participants will be treated with quilting suture and 50% with conventional closure. Patients are randomly divided into the 2 groups. All patients are blinded to the surgical treatment.This means that they do not know which surgical treatment they have received (quilting suture or conventional closure), The operating surgeon will not see the after the operation. Seroma assessment will be performed by other medical personnel, that do not know which surgical treatment has been given. In case of seroma a physician (not the operating surgeon) will perform the aspiration of seroma if needed.

Detailed description: Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalisation. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs The aim of this trial is to compare the efficacy of quilting suture of the dead space at the pectoral area and/or axilla with that of conventional suture in reducing the total volume of post-mastectomy and/or axillary drainage and seroma in female patients after surgical treatment of breast cancer.The study seeks primarily to determine if quilting suture compared to conventional suture after mastectomy/ALND reduces the total volume of axillary drainage until drain removal.

This single blind randomised phase III controlled superiority trial compares 2 surgical techniques: quilting suture and conventional suture. Patients will be assigned to one of 2 parallel groups: Arm A: quilting suture and Arm B: (no quilting suture): conventional wound closure.

Duration of accrual: 2 years - Duration of trial treatment: 1 day (surgery). Surgery procedure: Mastectomies or ALND dissections using a standardized technique, with multiple quilting sutures in the site of the mastectomy/in the dissected axilla or conventional closure without quilting. In both procedures placement of one drain into the breast and axilla or in the axillary cavity.

All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (Quality of Life: EQ5-D and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

At the study visits the following examinations will be performed: physical examination, blinded assessment of seroma, axillary drain volume, adverse events and surgical site infections.

The sample size is based on the primary endpoint, the total volume of axillary drainage. We assume a reduction in the total volume of axillary drainage of 200 ml in the intervention arm (application of quilting sutures) compared to the control arm (no application of sutures), which is based on literature and actual measurements in 14 patients. A total of 106 patients (53 in each group) will yield a power of 80% to detect this difference at a two-sided significance level of 0.05.

Eligibility criteria: Inclusion Criteria:

* ≥18 years-old female patients
* mastectomy alone, mastectomy and sentinel, mastectomy and axilla, axilla and tumorectomy or axilla alone
* patients with histo- or cytology proven breast cancer Union for International Cancer Control's (UICC)/American Joint Committee on Cancer (AJCC) stage I-III
* Fluency in either German or French
* The EQ-5D and BPI questionnaires must be completed by the patient at registration
* Patient has given written informed consent before registration.

Exclusion Criteria:

* Bilateral operation or reconstruction
* Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and/or filling out the questionnaires
* Pregnancy.

Primary outcomes:
measure: Total volume (ml) of axillary/breast drainage until drain removal.
timeFrame: up to 5 days
Secondary outcomes:
measure: Total duration (days) of breast/axillary drainage
timeFrame: 1-5 days
measure: Duration of postoperative hospital stay
timeFrame: 5-7 days
measure: Number of patients with clinically relevant seroma
timeFrame: From the date of surgery until 12 weeks after surgery
measure: Number of patients with lymphedema
timeFrame: From the date of surgery until week 12
measure: Adverse Events (AEs) due to surgical procedure
timeFrame: during 4 weeks after surgery
measure: Surgical morbidity
timeFrame: within the 12 weeks follow up after surgery
measure: Duration (number of days) of clinically relevant seroma aspiration period
timeFrame: from the date of surgery until 12 weeks after surgery
measure: Volume of axillary drainage per 24 hours in ml
timeFrame: up to 5 days
measure: Number of clinically relevant seroma aspirations
timeFrame: From the date of surgery until 12 weeks after surgery
measure: Total volume in ml of all clinically relevant seroma aspirations
timeFrame: From the date of surgery until 12 weeks after surgery
measure: Surgical morbidity
timeFrame: up to 2 hours
measure: Surgical morbidity
timeFrame: up to 2 hours
Other outcomes:
measure: Patient self-reported pain will be assessed with the Brief Pain Inventory (BPI) patient self-reported questionnaire
timeFrame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
measure: Patient Euro quality of life questionnaire (EQ-5D)
timeFrame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
measure: Health Economic Analysis (HEA)
timeFrame: at week 4 and week 12
Locations:
city: Bern
country: Switzerland
facility: Brustzentrum Bern
Study officials:
affiliation: Brustzentrum Bern
name: Gilles Berclaz
role: PRINCIPAL_INVESTIGATOR
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