Breast Cancer FemaleQuiltingNCT03902977
Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection
A study testing quilting and conventional suture in people with Breast Cancer Female, run by Lindenhofgruppe AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- quilting and conventional suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Feb 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- Bilateral operation or reconstruction
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and/or filling out the questionnaires
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- quilting, conventional suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quiltingProcedure or surgery
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
conventional sutureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | quilting Receives: Procedure: quilting |
| Arm B | Active comparator | conventional suture Receives: Procedure: conventional suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 days
Secondary outcomes (12)
Total duration (days) of breast/axillary drainage
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
Measured: 1-5 days
Duration of postoperative hospital stay
calculated from the date of surgery to the date of discharge (after surgery patients are hospitalized usually for 5 days)
Measured: 5-7 days
Number of patients with clinically relevant seroma
Clinically relevant seroma is defined as either causing strong discomfort or requiring aspiration
Measured: From the date of surgery until 12 weeks after surgery
Number of patients with lymphedema
increase of more than 2.5 cm in arm circumference
Measured: From the date of surgery until week 12
Adverse Events (AEs) due to surgical procedure
after surgery possible wound-related complications (e.g. haematoma requiring reoperation, skin flap necrosis) flap necrosis)
Measured: during 4 weeks after surgery
Surgical morbidity
number of outpatient visits (related to mastectomy/ALND) needed following participant's discharge
Measured: within the 12 weeks follow up after surgery
Duration (number of days) of clinically relevant seroma aspiration period
calculated until the date of the last clinically relevant seroma aspiration
Measured: from the date of surgery until 12 weeks after surgery
Volume of axillary drainage per 24 hours in ml
calculated as the total volume of axillary drainage in ml until drain removal divided by the total duration of axillary drainage in days
Measured: up to 5 days
Number of clinically relevant seroma aspirations
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
Measured: From the date of surgery until 12 weeks after surgery
Total volume in ml of all clinically relevant seroma aspirations
calculated in in ml
Measured: From the date of surgery until 12 weeks after surgery
Surgical morbidity
intraoperative blood loss calculated in ml from start to end of surgery
Measured: up to 2 hours
Surgical morbidity
duration of the surgical procedure from start to end of surgery
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start19 Feb 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenhofgruppe AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bern, StiftungLindenhof
- Responsible party
- Sponsor
- Investigators
- Gilles Berclaz, Principal investigator, Brustzentrum Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902977
- Sponsor's protocol ID
- BZ01/17
- Other IDs
- 17-17-F
- Acronym
- Quilting
- Status last verified
- Oct 2020
- First submitted
- 25 Mar 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Clinical Trial Unit of the University of Bern will perform the statistical analysis and will be involved in the publication
Publications
Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Effect of mechanical closure of dead space on seroma formation after breast surgery. Breast Cancer. 2006;13(3):260-5. doi: 10.2325/jbcs.13.260.
PubMed 16929119Barton A, Blitz M, Callahan D, Yakimets W, Adams D, Dabbs K. Early removal of postmastectomy drains is not beneficial: results from a halted randomized controlled trial. Am J Surg. 2006 May;191(5):652-6. doi: 10.1016/j.amjsurg.2006.01.037.
PubMed 16647354Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynecol Obstet. 1987 Dec;165(6):483-7.
PubMed 3686312Tejler G, Aspegren K. Complications and hospital stay after surgery for breast cancer: a prospective study of 385 patients. Br J Surg. 1985 Jul;72(7):542-4. doi: 10.1002/bjs.1800720714.
PubMed 4016536Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9.
PubMed 14602488Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.
PubMed 6359504Bryant M, Baum M. Postoperative seroma following mastectomy and axillary dissection. Br J Surg. 1987 Dec;74(12):1187. doi: 10.1002/bjs.1800741239. No abstract available.
PubMed 3427377Boostrom SY, Throckmorton AD, Boughey JC, Holifield AC, Zakaria S, Hoskin TL, Degnim AC. Incidence of clinically significant seroma after breast and axillary surgery. J Am Coll Surg. 2009 Jan;208(1):148-50. doi: 10.1016/j.jamcollsurg.2008.08.029. Epub 2008 Oct 2. No abstract available.
PubMed 19228516Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Pathophysiology of seroma in breast cancer. Breast Cancer. 2005;12(4):288-93. doi: 10.2325/jbcs.12.288.
PubMed 16286909Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.
PubMed 22693384Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995 Oct;40(5):292-4.
PubMed 8523301Gonzalez EA, Saltzstein EC, Riedner CS, Nelson BK. Seroma formation following breast cancer surgery. Breast J. 2003 Sep-Oct;9(5):385-8. doi: 10.1046/j.1524-4741.2003.09504.x.
PubMed 12968958van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
PubMed 21849243Hashemi E, Kaviani A, Najafi M, Ebrahimi M, Hooshmand H, Montazeri A. Seroma formation after surgery for breast cancer. World J Surg Oncol. 2004 Dec 9;2:44. doi: 10.1186/1477-7819-2-44.
PubMed 15588301Aitken DR, Hunsaker R, James AG. Prevention of seromas following mastectomy and axillary dissection. Surg Gynecol Obstet. 1984 Apr;158(4):327-30.
PubMed 6369582
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03902977
- Acronym / sponsor ID
- Quilting / BZ01/17
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lindenhofgruppe AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Bern, StiftungLindenhof
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: quiltingquilting |
| Arm B | Active comparator | Procedure: conventional sutureconventional suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (3 listed)
- Bilateral operation or reconstruction
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and/or filling out the questionnaires
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quiltingAfter 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 | Procedure or surgery | Arm A |
| conventional sutureAfter 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 | Procedure or surgery | Arm B |
Primary outcome
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.
12 secondary outcomes
Total duration (days) of breast/axillary drainage
Time frame: 1-5 days
Duration of postoperative hospital stay
Time frame: 5-7 days
Number of patients with clinically relevant seroma
Time frame: From the date of surgery until 12 weeks after surgery
Number of patients with lymphedema
Time frame: From the date of surgery until week 12
Adverse Events (AEs) due to surgical procedure
Time frame: during 4 weeks after surgery
Surgical morbidity
Time frame: within the 12 weeks follow up after surgery
Duration (number of days) of clinically relevant seroma aspiration period
Time frame: from the date of surgery until 12 weeks after surgery
Volume of axillary drainage per 24 hours in ml
Time frame: up to 5 days
Number of clinically relevant seroma aspirations
Time frame: From the date of surgery until 12 weeks after surgery
Total volume in ml of all clinically relevant seroma aspirations
Time frame: From the date of surgery until 12 weeks after surgery
Surgical morbidity
Time frame: up to 2 hours
Surgical morbidity
Time frame: up to 2 hours
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 16929119Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Effect of mechanical closure of dead space on seroma formation after breast surgery. Breast Cancer. 2006;13(3):260-5. doi: 10.2325/jbcs.13.260.
- Results publication: PubMed 16647354Barton A, Blitz M, Callahan D, Yakimets W, Adams D, Dabbs K. Early removal of postmastectomy drains is not beneficial: results from a halted randomized controlled trial. Am J Surg. 2006 May;191(5):652-6. doi: 10.1016/j.amjsurg.2006.01.037.
- Results publication: PubMed 3686312Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynecol Obstet. 1987 Dec;165(6):483-7.
- Results publication: PubMed 4016536Tejler G, Aspegren K. Complications and hospital stay after surgery for breast cancer: a prospective study of 385 patients. Br J Surg. 1985 Jul;72(7):542-4. doi: 10.1002/bjs.1800720714.
- Results publication: PubMed 14602488Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9.
- Results publication: PubMed 6359504Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.
- Results publication: PubMed 3427377Bryant M, Baum M. Postoperative seroma following mastectomy and axillary dissection. Br J Surg. 1987 Dec;74(12):1187. doi: 10.1002/bjs.1800741239. No abstract available.
- Results publication: PubMed 19228516Boostrom SY, Throckmorton AD, Boughey JC, Holifield AC, Zakaria S, Hoskin TL, Degnim AC. Incidence of clinically significant seroma after breast and axillary surgery. J Am Coll Surg. 2009 Jan;208(1):148-50. doi: 10.1016/j.jamcollsurg.2008.08.029. Epub 2008 Oct 2. No abstract available.
- Results publication: PubMed 16286909Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Pathophysiology of seroma in breast cancer. Breast Cancer. 2005;12(4):288-93. doi: 10.2325/jbcs.12.288.
- Results publication: PubMed 22693384Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.
- Results publication: PubMed 8523301Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995 Oct;40(5):292-4.
- Results publication: PubMed 12968958Gonzalez EA, Saltzstein EC, Riedner CS, Nelson BK. Seroma formation following breast cancer surgery. Breast J. 2003 Sep-Oct;9(5):385-8. doi: 10.1046/j.1524-4741.2003.09504.x.
- Individual participant dataSharing planned: Yes. The Clinical Trial Unit of the University of Bern will perform the statistical analysis and will be involved in the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Berclaz principal investigator
Brustzentrum Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quilting and conventional suture in people with Breast Cancer Female, run by Lindenhofgruppe AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume (ml) of axillary/breast drainage until drain removal. (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902977, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.