Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902977
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
University of Bern
StiftungLindenhof
Information provided by (Responsible Party):
Gilles Berclaz, MD PD, Brustzentrum Bern der Lindenhofgruppe

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Female Procedure: quilting Procedure: conventional suture Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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): qulting or conventional suture.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
quilting
Procedure: quilting
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

Active Comparator: Arm B
conventional suture
Procedure: conventional suture
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




Primary Outcome Measures :
  1. Total volume (ml) of axillary/breast drainage until drain removal. [ Time Frame: up to 5 days ]
    Blinded daily measurement of axillary drainage volume during hospital stay at 8.00 h a.m in the morning through nurses.


Secondary Outcome Measures :
  1. Total duration (days) of breast/axillary drainage [ Time Frame: 1-5 days ]
    calculated from the date of surgery to date of drain removal calculated drainage from the date of surgery to the date of axillary/breast drain removal

  2. Duration of postoperative hospital stay [ Time Frame: 5-7 days ]
    calculated from the date of surgery to the date of discharge (after surgery patients are hospitalized usually for 5 days)

  3. Number of patients with clinically relevant seroma [ Time Frame: From the date of surgery until 12 weeks after surgery ]
    Clinically relevant seroma is defined as either causing strong discomfort or requiring aspiration

  4. Number of patients with lymphedema [ Time Frame: From the date of surgery until week 12 ]
    increase of more than 2.5 cm in arm circumference

  5. Adverse Events (AEs) due to surgical procedure [ Time Frame: during 4 weeks after surgery ]
    after surgery possible wound-related complications (e.g. haematoma requiring reoperation, skin flap necrosis) flap necrosis)

  6. Surgical morbidity [ Time Frame: within the 12 weeks follow up after surgery ]
    number of outpatient visits (related to mastectomy/ALND) needed following participant's discharge

  7. Duration (number of days) of clinically relevant seroma aspiration period [ Time Frame: from the date of surgery until 12 weeks after surgery ]
    calculated until the date of the last clinically relevant seroma aspiration

  8. Volume of axillary drainage per 24 hours in ml [ Time Frame: up to 5 days ]
    calculated as the total volume of axillary drainage in ml until drain removal divided by the total duration of axillary drainage in days

  9. Number of clinically relevant seroma aspirations [ Time Frame: From the date of surgery until 12 weeks after surgery ]
    Aspiration is performed if the patient experiences strong discomfort, in case of impaired ipsilateral shoulder function, if higher risk of surgical infection and in case pain interferences with daily functions

  10. Total volume in ml of all clinically relevant seroma aspirations [ Time Frame: From the date of surgery until 12 weeks after surgery ]
    calculated in in ml

  11. Surgical morbidity [ Time Frame: up to 2 hours ]
    intraoperative blood loss calculated in ml from start to end of surgery

  12. Surgical morbidity [ Time Frame: up to 2 hours ]
    duration of the surgical procedure from start to end of surgery


Other Outcome Measures:
  1. Patient self-reported pain will be assessed with the Brief Pain Inventory (BPI) patient self-reported questionnaire [ Time Frame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery ]
    This questionnaire is a well validated and commonly used self-report measure to assess the severity of pain and the interference of pain with daily activities as well as the quality of life, patient's subjective experience of disease and treatment. The BPI assesses pain at its "worst," "least," "average," and "now" (current pain) on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) during the past 24 hours A clinically meaningful change in worst pain is defined as a change from baseline of at least 2 points in either direction. The BPI measures how much pain has interfered general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50% or four of seven of the total items have been completed on a given administration.

  2. Patient Euro quality of life questionnaire (EQ-5D) [ Time Frame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery ]

    EuroQol Group developed the questionnaire to describe and value health-related quality of life patient's subjective experience of disease and treatment. This includes 5 assessments: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each assessment has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient ticks the box against the most appropriate statement in each of the 5 dimensions, which are summed in a 5-digit number describing the respondent's health state: having no problems for 1, slight problems for 2, moderate problems for 3, severe problems for 4 and extreme problems for 5.

    On the form there is also a scale with numbers from 0 to 100. 100 is the best health and 0 the worst health the patient can imagine. The patient has to tick the appropriate number.


  3. Health Economic Analysis (HEA) [ Time Frame: at week 4 and week 12 ]
    forms are completed by the investigator and collect data on hospitalizations, rehabilitation, stays at nursing homes, out-patient visits performed by physicians working at practice offices or at hospitals, treatments as physiotherapy,nutrition counseling or alternative therapies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902977


Contacts
Layout table for location contacts
Contact: Gilles Berclaz, PD MD +41 (0)31 309 95 30 gilles.berclaz@lindenhofgruppe.ch
Contact: Claudia Gübelin, MD +41 (0)31 309 95 18 claudia.guebelin@lindenhofgruppe.ch

Locations
Layout table for location information
Switzerland
Brustzentrum Bern Recruiting
Bern, Switzerland, 3012
Contact: Gilles Berclaz, PD MD    +41 (0)31 309 95 30    gilles.berclaz@lindenhofgruppe.ch   
Contact: Claudia Gübelin, MD    +41 (0)31 309 95 18    claudia.guebelin@lindenhofgruppe.ch   
Sponsors and Collaborators
Gilles Berclaz, MD PD
University of Bern
StiftungLindenhof
Investigators
Layout table for investigator information
Principal Investigator: Gilles Berclaz Brustzentrum Bern
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Gilles Berclaz, MD PD, Scientific Director Brustzentrum Bern, Brustzentrum Bern der Lindenhofgruppe
ClinicalTrials.gov Identifier: NCT03902977    
Other Study ID Numbers: BZ01/17
17-17-F ( Other Identifier: StiftungLindenhof )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Clinical Trial Unit of the University of Bern will perform the statistical analysis and will be involved in the publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 3 years after study end
Access Criteria: 3 years after study end

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases