SeromaSEROMNCT05901064
Evaluation of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients
A study testing Axillary clearance in people with Seroma, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seroma
- What is being tested?
- Axillary clearance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2021to 31 Dec 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- All patients who will undergo axillary evacuation
- Informed consent
Who cannot join
- Patients who have previously undergone axillary evacuation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
University hospital of Linkoping
Linköping, Östergötland County, 58185
Carlos Dussan, MD, PhD, +46706390116, carlos.dussan.luberth@regionostergotland.se
Ervin Beka, MD, PhD-student, +46738430968, ervin.beka@regionostergotland.se
About this study
Official title: Economic Comparison Between the Use of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients
Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.
Read the detailed description
Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance.
The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm.
Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system.
Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery[1, 2]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®.
In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group.
- Conditions
- Seroma
- Being tested
- Axillary clearance
- Keywords
- Seroma, Axillary dissection, Complications
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary clearanceProcedure or surgery
Also called Axillary dissection
Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla
| Study group | Role | What they receive |
|---|---|---|
| Harmonic Focus | Active comparator | Patients that are operated with Harmonic Focus Receives: Procedure: Axillary clearance |
| Diathermy | Active comparator | Patients that are operated with conventional diathermy Receives: Procedure: Axillary clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients.
Unit of measures: Costs of extra visits with nurse, physiotherapist or surgeon, antibiotics, PICO, re-interventions due to complications, microbiological cultures, incapacity to work, hospitalizations
Measured: 12 months
Secondary outcomes (2)
Function before and after breast cancer treatment. Lymph-ICF Survey
Questionnaire
Measured: 12 months
Complication frequency between the use of ultrasonic scissors and diathermy for axillary
Comlplication frequency comparison
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start21 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SeromaStudies 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
- Double blinded randomized prospective study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CLuberth, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901064
- Sponsor's protocol ID
- LinkoepingU
- Acronym
- SEROM
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bohm D, Kubitza A, Lebrecht A, Schmidt M, Gerhold-Ay A, Battista M, Stewen K, Solbach C, Kolbl H. Prospective randomized comparison of conventional instruments and the Harmonic Focus((R)) device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol. 2012 Feb;38(2):118-24. doi: 10.1016/j.ejso.2011.11.003. Epub 2011 Dec 5.
PubMed 22152942Faisal M, Fathy H, Shaban H, Abuelela ST, Marie A, Khaled I. A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial. Patient Saf Surg. 2018 May 17;12:8. doi: 10.1186/s13037-018-0155-3. eCollection 2018.
PubMed 29796089Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
PubMed 21304082Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.
PubMed 23491275de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y.
PubMed 28549453Sowa Y, Numajiri T, Kawarazaki A, Sakaguchi K, Taguchi T, Nishino K. Preventive effects on seroma formation with use of the harmonic focus shears after breast reconstruction with the latissimus dorsi flap. J Plast Surg Hand Surg. 2016 Dec;50(6):349-353. doi: 10.1080/2000656X.2016.1178129. Epub 2016 May 5.
PubMed 27146859Selvendran S, Cheluvappa R, Tr Ng VK, Yarrow S, Pang TC, Segara D, Soon P. Efficacy of harmonic focus scalpel in seroma prevention after axillary clearance. Int J Surg. 2016 Jun;30:116-20. doi: 10.1016/j.ijsu.2016.04.041. Epub 2016 Apr 29.
PubMed 27142863Hung SH, Chu D, Chen FM, Chen T, Chen RC. Evaluation of the harmonic scalpel in breast conserving and axillary staging surgery. J Chin Med Assoc. 2012 Oct;75(10):519-23. doi: 10.1016/j.jcma.2012.07.006. Epub 2012 Sep 15.
PubMed 23089404He Q, Zhuang D, Zheng L, Fan Z, Zhou P, Zhu J, Lv Z, Chai J, Cao L. Harmonic focus versus electrocautery in axillary lymph node dissection for breast cancer: a randomized clinical study. Clin Breast Cancer. 2012 Dec;12(6):454-8. doi: 10.1016/j.clbc.2012.07.014. Epub 2012 Oct 3.
PubMed 23040644
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Comparison Between the Use of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05901064
- Acronym / sponsor ID
- SEROM / LinkoepingU
- Conditions
- Seroma
- Keywords
- Seroma, Axillary dissection, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2023 (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 surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.
Detailed description
Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance.
The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm.
Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system.
Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery[1, 2]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®.
In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blinded randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Harmonic Focus | Active comparator | Procedure: Axillary clearancePatients that are operated with Harmonic Focus |
| Diathermy | Active comparator | Procedure: Axillary clearancePatients that are operated with conventional diathermy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- All patients who will undergo axillary evacuation
- Informed consent
Key exclusion criteria (1 listed)
- Patients who have previously undergone axillary evacuation.
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 |
|---|---|---|
| Axillary clearanceAlso: Axillary dissectionEvaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla | Procedure or surgery | Diathermy, Harmonic Focus |
Primary outcome
Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients.
Time frame: 12 months
Unit of measures: Costs of extra visits with nurse, physiotherapist or surgeon, antibiotics, PICO, re-interventions due to complications, microbiological cultures, incapacity to work, hospitalizations
2 secondary outcomes
Function before and after breast cancer treatment. Lymph-ICF Survey
Time frame: 12 months
Complication frequency between the use of ultrasonic scissors and diathermy for axillary
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 22152942Bohm D, Kubitza A, Lebrecht A, Schmidt M, Gerhold-Ay A, Battista M, Stewen K, Solbach C, Kolbl H. Prospective randomized comparison of conventional instruments and the Harmonic Focus((R)) device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol. 2012 Feb;38(2):118-24. doi: 10.1016/j.ejso.2011.11.003. Epub 2011 Dec 5.
- Background: PubMed 29796089Faisal M, Fathy H, Shaban H, Abuelela ST, Marie A, Khaled I. A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial. Patient Saf Surg. 2018 May 17;12:8. doi: 10.1186/s13037-018-0155-3. eCollection 2018.
- Background: PubMed 21304082Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
- Background: PubMed 23491275Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.
- Background: PubMed 28549453de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y.
- Background: PubMed 27146859Sowa Y, Numajiri T, Kawarazaki A, Sakaguchi K, Taguchi T, Nishino K. Preventive effects on seroma formation with use of the harmonic focus shears after breast reconstruction with the latissimus dorsi flap. J Plast Surg Hand Surg. 2016 Dec;50(6):349-353. doi: 10.1080/2000656X.2016.1178129. Epub 2016 May 5.
- Background: PubMed 27142863Selvendran S, Cheluvappa R, Tr Ng VK, Yarrow S, Pang TC, Segara D, Soon P. Efficacy of harmonic focus scalpel in seroma prevention after axillary clearance. Int J Surg. 2016 Jun;30:116-20. doi: 10.1016/j.ijsu.2016.04.041. Epub 2016 Apr 29.
- Background: PubMed 23089404Hung SH, Chu D, Chen FM, Chen T, Chen RC. Evaluation of the harmonic scalpel in breast conserving and axillary staging surgery. J Chin Med Assoc. 2012 Oct;75(10):519-23. doi: 10.1016/j.jcma.2012.07.006. Epub 2012 Sep 15.
- Background: PubMed 23040644He Q, Zhuang D, Zheng L, Fan Z, Zhou P, Zhu J, Lv Z, Chai J, Cao L. Harmonic focus versus electrocautery in axillary lymph node dissection for breast cancer: a randomized clinical study. Clin Breast Cancer. 2012 Dec;12(6):454-8. doi: 10.1016/j.clbc.2012.07.014. Epub 2012 Oct 3.
- Individual participant dataSharing planned: No
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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.
University hospital of Linkoping
Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary clearance in people with Seroma, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Jun 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients. (time frame: 12 months). 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 NCT05901064, which also lists 9 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 13 Jun 2023.