Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection

NCT03902977 | Terminated

• 2 other identifiers: BZ01/1717-17-F
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Total volume (ml) of axillary/breast drainage until drain removal.

  Blinded daily measurement of axillary drainage volume during hospital stay at 8.00 h a.m in the morning through nurses.

  up to 5 days

Secondary Outcomes (12)

• Total duration (days) of breast/axillary drainage

  1-5 days

• Duration of postoperative hospital stay

  5-7 days

• Number of patients with clinically relevant seroma

  From the date of surgery until 12 weeks after surgery

• Number of patients with lymphedema

  From the date of surgery until week 12

• Adverse Events (AEs) due to surgical procedure

  during 4 weeks after surgery

Other Outcomes (3)

• Patient self-reported pain will be assessed with the Brief Pain Inventory (BPI) patient self-reported questionnaire

  every day during the first 2 weeks after the operation and at week 4 and 12 after surgery

• Patient Euro quality of life questionnaire (EQ-5D)

  every day during the first 2 weeks after the operation and at week 4 and 12 after surgery

• Health Economic Analysis (HEA)

  at week 4 and week 12

Study Arms (2)

Arm A

EXPERIMENTAL

quilting

Procedure: quilting

Arm B

ACTIVE COMPARATOR

conventional suture

Procedure: conventional suture

Interventions

quilting PROCEDURE

After mastectomies or ALND dissections using standard technique for wound closure multiple sutures (monocryl 3.0) every 3 to 4 cm in the site of the mastectomy (1 or 2 rows) or in the dissected axilla.Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision

Arm A

conventional suture PROCEDURE

After mastectomies or ALND dissections standard technique for wound closure. Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Lindenhofgruppe AG: lead
• University of Bern: collaborator
• StiftungLindenhof: collaborator

Study Sites (1)

Brustzentrum Bern

Bern, 3012, Switzerland

Location

Related Publications (34)

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Study Officials

• Gilles Berclaz

  Brustzentrum Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The surgeon who operates the patient will neither perform the follow up visits nor contact other investigators. A blinded investigator will see the patient at the following visits after surgery: week 1, week 4 and week 12. In case the patient develops a seroma which needs aspiration, aspiration will be performed by the blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 4, 2019
• Study Start: February 19, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 3 years after study end
• Access Criteria: 3 years after study end

Locations

CH (1)