SeromaNCT03590704
Safety of the Use of Compressive Taping in Seroma
A study testing Vitaltape® bandage in people with Seroma, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
Seroma is the most common complication at the beginning of healing after surgery for breast cancer treatment. Its incidence varies in the literature from 2.5 to 90% and is defined as a collection of serous fluid that develops through skin flaps in the dead space after mastectomy or axillary dissection. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Seroma
- What is being tested?
- Vitaltape® bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2017to 19 Sep 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who developed seroma after surgical treatment for breast cancer, detected by nursing team.
Who cannot join
- bilateral breast cancer
- neoadjuvant radiotherapy
- wound infection
- reporting of autoimmune diseases (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma)
- patients with difficulties of understanding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tolerance and Cutaneous Reaction to the Use of Compressive Taping in the Seroma After Surgical Treatment of Breast Cancer
Seroma is the most common complication at the beginning of healing after surgery for breast cancer treatment. Its incidence varies in the literature from 2.5 to 90% and is defined as a collection of serous fluid that develops through skin flaps in the dead space after mastectomy or axillary dissection. The physiopathology for seroma formation has not yet been fully understood, but appears to be multifactorial with surgery being the main factor. Although seroma formation is not a threat to life, it can lead to important morbidity due to associated with necrosis, dehiscence, predisposition to sepsis, reduction of shoulder functions due to muscle weakness due to restriction of movement, prolonging the recovery period and, consequently, leading to delay in adjuvant therapy. The best seroma treatment is still not well defined in the literature and the compressive therapy aims to rebalance fluid exchange between the lymphatic system and blood, having as effects the increase of the interstitial pressure, the improvement of the effectiveness of muscular work, increased resistance of the skin and prevention new collection of interstitial fluid. Recently, the Kinesio® Taping method were inserted into clinical practice for its ability to reduce pain and local swelling. Objective: To evaluate the safety of taping in the seroma after surgical treatment of breast cancer. Methodology: This is a pre and post-clinical application of taping on the seroma in women submitted to surgical treatment for breast cancer in the Cancer Hospital III / INCA. The intervention was performed by applying the compression bandage over the seroma region for an average of five days, when the reassessment was performed.
Read the detailed description
Patients identified by the nursing team with seroma and with indication of aspiration puncture, will be evaluated for eligibility criteria. Those who agree to participate in the study will be assessed and submitted to the intervention on the same day, they will remain with four days approximately for nursing and physiotherapy revaluation for intervention suspension. The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the fluctuation region (seroma) and finalized with another base without stretching, of 2 centimeters, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. The interview will be conducted at the entrance to the study, prior to the intervention and the end of the study. In the initial interview will be collected sociodemographic data and life habits. They will be evaluated by questionnaire as the local symptoms caused by the use of the bandages, the tolerance and feeling / referred sensation during and at the end of intervention period, the percentage of seroma volume alteration before and after the use of the bandage, the number of days of use and bandage detachment. All reviews will be carried out by another professional who will not make the interventions. From the hospital record, information will be collected regarding the oncology treatment, histopathological report and clinical data on curative care.
- Conditions
- Seroma
- Being tested
- Vitaltape® bandage
- Keywords
- Taping, Seroma, Safety, Breast Cancer, Physiotherapy
- 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.
Vitaltape® bandageDevice
The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Vitaltape® bandage | Experimental | The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. They will remain four days approximately for revaluation and intervention suspension. Receives: Device: Vitaltape® bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess dermal changes of using the compressive bandage as a treatment for seroma
Dermal changes were evaluated at the site of application of the bandage of the 35 participants, such as discoloration, local temperature increase, skin peeling, presence of wound and formation of bullous lesions at the site of application of neuromuscular bandage, graded in mild, moderate or severe , according to the severity of the change, from a semi-structured questionnaire.
Measured: 4 to 5 days
Secondary outcomes (4)
Seroma volume difference
It was verified from the comparison between the volumes of liquid punctured by nursing punctured by the nursing team on the day of application and on the return of the patient
Measured: 4 to 5 days
It was evaluated the patient's tolerance to the use of compressive bandages
It was counted how many of the 35 patients felt pain, itching, burning, discomfort, tightness, increased fluctuation (seroma) at the place where the bandage was applied. The symptoms were graded according to the Visual Numeric Scale (0-10), where 0 was considered to be sensations and 10 was unbearable sensation with the use of bandages.
Measured: 4 to 5 days
It was evaluated the patient satisfaction with the use of compressive bandages
It was evaluated how many of the 35 participants were satisfied with the use of the bandage, being graded according to the Visual Numerical Scale, where 0 was considered totally dissatisfied and 10 was totally satisfied.
Measured: 4 to 5 days
It was assessed whether the patient felt secure with compressive bandage
It was evaluated how many of the 35 participants felt safe using the bandage. For each participant, safety was graded according to the Visual Numerical Scale, where 0 was considered totally dissatisfied and 10 was completely satisfied.
Measured: 4 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start6 Jun 2017
- Primary completion29 Aug 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erica Fabro, Master, Principal investigator, INCA - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590704
- Sponsor's protocol ID
- INCASafetySeroma
- Status last verified
- Apr 2021
- First submitted
- 30 Oct 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fabro EAN, Teodozio CGC, Costa RM, Macedo FO, Cardoso ACDDLM, Jacob RBE, Thuler LCS, Bergmann A. Clinical Experience with Compression Taping to Treat Seroma After Breast Cancer Surgery: A Medical Device Clinical Study. Adv Skin Wound Care. 2022 Jul 1;35(7):1-6. doi: 10.1097/01.ASW.0000831068.34587.3d.
PubMed 35723961
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerance and Cutaneous Reaction to the Use of Compressive Taping in the Seroma After Surgical Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT03590704
- Acronym / sponsor ID
- INCASafetySeroma
- Conditions
- Seroma
- Keywords
- Taping, Seroma, Safety, Breast Cancer, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 18 Jul 2018 (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.
Seroma is the most common complication at the beginning of healing after surgery for breast cancer treatment. Its incidence varies in the literature from 2.5 to 90% and is defined as a collection of serous fluid that develops through skin flaps in the dead space after mastectomy or axillary dissection. The physiopathology for seroma formation has not yet been fully understood, but appears to be multifactorial with surgery being the main factor. Although seroma formation is not a threat to life, it can lead to important morbidity due to associated with necrosis, dehiscence, predisposition to sepsis, reduction of shoulder functions due to muscle weakness due to restriction of movement, prolonging the recovery period and, consequently, leading to delay in adjuvant therapy. The best seroma treatment is still not well defined in the literature and the compressive therapy aims to rebalance fluid exchange between the lymphatic system and blood, having as effects the increase of the interstitial pressure, the improvement of the effectiveness of muscular work, increased resistance of the skin and prevention new collection of interstitial fluid. Recently, the Kinesio® Taping method were inserted into clinical practice for its ability to reduce pain and local swelling. Objective: To evaluate the safety of taping in the seroma after surgical treatment of breast cancer. Methodology: This is a pre and post-clinical application of taping on the seroma in women submitted to surgical treatment for breast cancer in the Cancer Hospital III / INCA. The intervention was performed by applying the compression bandage over the seroma region for an average of five days, when the reassessment was performed.
Detailed description
Patients identified by the nursing team with seroma and with indication of aspiration puncture, will be evaluated for eligibility criteria. Those who agree to participate in the study will be assessed and submitted to the intervention on the same day, they will remain with four days approximately for nursing and physiotherapy revaluation for intervention suspension. The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the fluctuation region (seroma) and finalized with another base without stretching, of 2 centimeters, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. The interview will be conducted at the entrance to the study, prior to the intervention and the end of the study. In the initial interview will be collected sociodemographic data and life habits. They will be evaluated by questionnaire as the local symptoms caused by the use of the bandages, the tolerance and feeling / referred sensation during and at the end of intervention period, the percentage of seroma volume alteration before and after the use of the bandage, the number of days of use and bandage detachment. All reviews will be carried out by another professional who will not make the interventions. From the hospital record, information will be collected regarding the oncology treatment, histopathological report and clinical data on curative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Vitaltape® bandage | Experimental | Device: Vitaltape® bandageThe neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. They will remain four days approximately for revaluation and intervention suspension. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who developed seroma after surgical treatment for breast cancer, detected by nursing team.
Key exclusion criteria (5 listed)
- bilateral breast cancer
- neoadjuvant radiotherapy
- wound infection
- reporting of autoimmune diseases (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma)
- patients with difficulties of 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 |
|---|---|---|
| Vitaltape® bandageThe neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. | Device | Intervention Vitaltape® bandage |
Primary outcome
Assess dermal changes of using the compressive bandage as a treatment for seroma
Time frame: 4 to 5 days
Dermal changes were evaluated at the site of application of the bandage of the 35 participants, such as discoloration, local temperature increase, skin peeling, presence of wound and formation of bullous lesions at the site of application of neuromuscular bandage, graded in mild, moderate or severe , according to the severity of the change, from a semi-structured questionnaire.
4 secondary outcomes
Seroma volume difference
Time frame: 4 to 5 days
It was evaluated the patient's tolerance to the use of compressive bandages
Time frame: 4 to 5 days
It was evaluated the patient satisfaction with the use of compressive bandages
Time frame: 4 to 5 days
It was assessed whether the patient felt secure with compressive bandage
Time frame: 4 to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 35723961Fabro EAN, Teodozio CGC, Costa RM, Macedo FO, Cardoso ACDDLM, Jacob RBE, Thuler LCS, Bergmann A. Clinical Experience with Compression Taping to Treat Seroma After Breast Cancer Surgery: A Medical Device Clinical Study. Adv Skin Wound Care. 2022 Jul 1;35(7):1-6. doi: 10.1097/01.ASW.0000831068.34587.3d.
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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 Vitaltape® 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 1 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: finished, as of the sponsor's last update on 19 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess dermal changes of using the compressive bandage as a treatment for seroma (time frame: 4 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 NCT03590704, which also lists 1 linked publication.
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 19 Apr 2021.