SeromaNCT04471142
Effectiveness of Compressive Bandage Use in Seroma Prevention
A study testing neuromuscular bandage in people with Seroma, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Seroma
- What is being tested?
- neuromuscular bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Nov 2021to 30 Mar 2023
- 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
- Women aged 18 and over
- underwent mastectomy assurgical treatment for breast cancer.
Who cannot join
- bilateral breast cancer;
- patient undergoing neoadjuvant radiotherapy;
- infection in the surgical wound or hematoma;
- autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma);
- patients with difficulties in understanding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer Surgery
INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p <0.20.
Read the detailed description
This is a randomized clinical trial with women undergoing surgical treatment for breast cancer at Cancer Hospital III / INCA. All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing in the hospital, those considered eligible will be informed about the study and no obligation to participate through free and informed consent. Upon acceptance, patients will be randomized to the intervention or control group, which will be performed by lot at the time the patient enters the study. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. This choice was chosen to avoid influences of the therapist or patient's preference over the intervention. The patients will be oriented in relation to the group they are inserted and what monitoring will be performed while the patient is under the care of the dressing. All evaluations, intervention and data collection will be performed by trained professionals qualified for this purpose. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). Patients allocated to this group on the day of the first dressing, before hospital discharge, according to the institutional routine, are instructed by the nursing staff to wash the plastron region with cold, boiled filtered water and to return within one week at the outpatient clinic. The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and definitive removal on the seventh day when it will be scheduled for return in nursing care. Should any complications occur due to the use of the bandage, the patients will be advised to remove the material at home and will be suspended from the research protocol. At the end of the seven days, the patients will be reevaluated. Prior to the application of the bandage will be made the antisepsis of the skin and placement of the transparent and sterile film dressing over the region of the scar points to protect the scar. The 5 cm wide Vitaltape® neuromuscular bandage will be used with maximum stretching over the plastron region and finished with two ends of two to three centimeters without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics. All applications will be performed by the same physical therapist. Group B: control group. The patient will follow the institution's routine only with the suction drain. All patients will be instructed to do the same care with the suction drain according to the institutional routine.
- Conditions
- Seroma
- Being tested
- neuromuscular bandage
- Keywords
- physiotherapy, seroma, breast cancer, taping
- Medical subject headings
- Seroma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular bandageDevice
Also called compressive taping, compressiva bandage
After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution). Receives: Device: neuromuscular bandage |
| Group B | No intervention | Group control. The patient will follow the institution's routine with only the suction drain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma Incidence
the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained.
Measured: 30 days
Seroma volume
the total volume drained and the number of aspirations will be considered necessary until resolution of the picture.
Measured: 30 days
Permanence time with the Suction Drain
The permanence time (in days) will be checked with the suction drain, as reported by the dressing team.
Measured: 15 days
Secondary outcomes (2)
Safety of the use of the compressive bandage in mastectomized women
The dermal changes will be evaluated at the location of the bandage application of the 135 participants in the intervention group, such as discoloration, increased local temperature, skin peeling, presence of a wound and formation of bullous lesions at the site of the application of the neuromuscular bandage, graded in light, moderate or severe, according to the severity of the change, from a semi-structured questionnaire.
Measured: 7 days
To assess the tolerance reported by the patient to the use of compressive taping
The symptoms of pain, itching, burning, discomfort, tightness, increased fluctuation of the seroma at the site of application of the bandage of the 135 participants will be evaluated. The symptoms will be graded according to the Visual Numeric Scale (0-10), where 0 will be considered no sensation and 10 unbearable sensation with the use of the bandage.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start8 Nov 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erica Alves Nogueira Fabro, Instituto Nacional de Cancer, Brazil
- Investigators
- Erica Fabro, Master, Principal investigator, INCA - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471142
- Sponsor's protocol ID
- Instituto Nacional do Câncer
- Status last verified
- Sep 2021
- First submitted
- 10 Jul 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fabro EAN, Costa RM, Fernandes MC, Ximenes MA, Nogueira DA, Soares NB, Thuler LCS, Bergmann A. Seroma incidence and risk factors in women undergoing mastectomies as surgical breast cancer treatment. Support Care Cancer. 2024 Sep 25;32(10):688. doi: 10.1007/s00520-024-08881-w.
PubMed 39322817Fernandes MC, Fabro EAN, Ximenes MA, Costa RMM, Soares NB, Aguiar SS, Thuler LCS, Bergmann A. Compressive taping to prevent postmastectomy seroma: patient adherence and satisfaction. BMJ Support Palliat Care. 2024 May 17:spcare-2024-004912. doi: 10.1136/spcare-2024-004912. Online ahead of print.
PubMed 38760081
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04471142
- Acronym / sponsor ID
- Instituto Nacional do Câncer
- Conditions
- Seroma
- Keywords
- physiotherapy, seroma, breast cancer, taping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 8 Nov 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 15 Jul 2020 (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.
INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p <0.20.
Detailed description
This is a randomized clinical trial with women undergoing surgical treatment for breast cancer at Cancer Hospital III / INCA. All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing in the hospital, those considered eligible will be informed about the study and no obligation to participate through free and informed consent. Upon acceptance, patients will be randomized to the intervention or control group, which will be performed by lot at the time the patient enters the study. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. This choice was chosen to avoid influences of the therapist or patient's preference over the intervention. The patients will be oriented in relation to the group they are inserted and what monitoring will be performed while the patient is under the care of the dressing. All evaluations, intervention and data collection will be performed by trained professionals qualified for this purpose. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). Patients allocated to this group on the day of the first dressing, before hospital discharge, according to the institutional routine, are instructed by the nursing staff to wash the plastron region with cold, boiled filtered water and to return within one week at the outpatient clinic. The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and definitive removal on the seventh day when it will be scheduled for return in nursing care. Should any complications occur due to the use of the bandage, the patients will be advised to remove the material at home and will be suspended from the research protocol. At the end of the seven days, the patients will be reevaluated. Prior to the application of the bandage will be made the antisepsis of the skin and placement of the transparent and sterile film dressing over the region of the scar points to protect the scar. The 5 cm wide Vitaltape® neuromuscular bandage will be used with maximum stretching over the plastron region and finished with two ends of two to three centimeters without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics. All applications will be performed by the same physical therapist. Group B: control group. The patient will follow the institution's routine only with the suction drain. All patients will be instructed to do the same care with the suction drain according to the institutional routine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: neuromuscular bandageIntervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution). |
| Group B | No intervention | –Group control. The patient will follow the institution's routine with only the suction drain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 and over
- underwent mastectomy assurgical treatment for breast cancer.
Key exclusion criteria (5 listed)
- bilateral breast cancer;
- patient undergoing neoadjuvant radiotherapy;
- infection in the surgical wound or hematoma;
- autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma);
- patients with difficulties in understanding.
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 |
|---|---|---|
| neuromuscular bandageAlso: compressive taping, compressiva bandageAfter the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics. | Device | Group A |
Primary outcome
Seroma Incidence
Time frame: 30 days
the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained.
Seroma volume
Time frame: 30 days
the total volume drained and the number of aspirations will be considered necessary until resolution of the picture.
Permanence time with the Suction Drain
Time frame: 15 days
The permanence time (in days) will be checked with the suction drain, as reported by the dressing team.
2 secondary outcomes
Safety of the use of the compressive bandage in mastectomized women
Time frame: 7 days
To assess the tolerance reported by the patient to the use of compressive taping
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 39322817Fabro EAN, Costa RM, Fernandes MC, Ximenes MA, Nogueira DA, Soares NB, Thuler LCS, Bergmann A. Seroma incidence and risk factors in women undergoing mastectomies as surgical breast cancer treatment. Support Care Cancer. 2024 Sep 25;32(10):688. doi: 10.1007/s00520-024-08881-w.
- Derived from this study: PubMed 38760081Fernandes MC, Fabro EAN, Ximenes MA, Costa RMM, Soares NB, Aguiar SS, Thuler LCS, Bergmann A. Compressive taping to prevent postmastectomy seroma: patient adherence and satisfaction. BMJ Support Palliat Care. 2024 May 17:spcare-2024-004912. doi: 10.1136/spcare-2024-004912. Online ahead of print.
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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.
Erica Fabro, Master principal investigator
INCA - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular bandage in people with Seroma, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 2 inclusion and 5 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 21 Sep 2021. 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 Brazil. 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?
Contact Erica Fabro, Master (55 21 993971746, efabro@inca.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma Incidence (time frame: 30 days). The study lists 3 primary outcomes in all. 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 NCT04471142, which also lists 2 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 21 Sep 2021.