Quality of LifeNCT02864186
The Benefits of the Use of a Support Bra in Women Undergoing Coronary Artery By-Pass Graft Surgery
A study testing surgical support bra and common support bra in people with Quality of Life and Wound Complications, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
That study have the primary purpose identify if exist difference to the healing and quality of life between women that use of a surgical support bra, common support bra and without support bra after coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Wound Complications, Pain
- What is being tested?
- surgical support bra and common support bra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jan 2015to 30 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who undergoing coronary artery bypass graft surgery
- Women who signed the term consent and informed
Who cannot join
- Women who have had any breast surgery
- Women who undergoing radiotherapy to the thorax.
- Women with cognitive impairments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor), Univ. of Sao Paulo Medical School
São Paulo, 05403000
About this study
Official title: A Randomized Study to Test the Hypothesis That a Support Bra Will Improve Healing and Quality of Life After Coronary Artery By-Pass Graft (CABG)
That study have the primary purpose identify if exist difference to the healing and quality of life between women that use of a surgical support bra, common support bra and without support bra after coronary artery bypass graft surgery.
To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality of life life through specific instruments.
Read the detailed description
The patients will be randomized and share into three groups: women after coronary artery bypass surgery use surgical support bra, women after coronary artery bypass surgery use common support bra and those who will not use any support bra.
They will be can tracked and invited to participate in the study few days before the surgery or during the post operatory (2 - 6 days after surgery). The assessement and the intervention must be start in the inpatient unit from the 2nd to 6th post operatory until their discharge.
Initially, it will be apply a questionnaire of quality of life (SF36) to assess the quality of life before the surgical procedure. In this moment, will be measured for breast size and also wil be identify the risk factors through a brief historical.
During the stay in the hospital, the patients will be assessed on a daily basis with respect to the following: pain (verbal numerical scale) and wound appearance.
The questionnaire of quality of life(SF36) will be applied again for more three times, about one month, two months and six months after the discharge together with the assessement to the pain and wound healing.
- Conditions
- Quality of Life, Wound Complications, Pain
- Being tested
- control, surgical support bra, common support bra
- Keywords
- Pain, Quality of life, wound healing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlDevice
Women wont use support bra 24 hours a days for six months
surgical support braDevice
Women will use surgical support bra 24 hours a day for six months
common support braDevice
Women will use common support bra 24 hours a day for six months
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Women wont use support bra for six months Receives: Device: control |
| surgical support bra | Active comparator | Women will use surgical support bra 24 hours a day for six months Receives: Device: surgical support bra |
| common support bra | Active comparator | Women will use common support bra 24 hours a day for six months Receives: Device: common support bra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
Measured: at six months after surgery
Secondary outcomes (3)
Quality of Life pre cardiac surgery - SF36
Measured: one day before surgery and then at one, two and six months
Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records
Measured: at six months after surgery
Use of antibiotics and painkillers - Medical Prescription
Measured: at six months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start26 Jan 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
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 Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Antonio M. Cesar, University of Sao Paulo
- Investigators
- LUIZ AM CESAR, MD, PhD, Principal investigator, INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864186
- Sponsor's protocol ID
- SDC4123/14/103
- Status last verified
- Feb 2021
- First submitted
- 18 Jul 2016
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Silva TRA, Ono JN, Miname FCBR, Gowdak LHW, Mioto BM, Santos RBD, Dallan LRP, Machado Cesar LA. Benefits of using a support bra in women undergoing coronary artery bypass graft surgery: A randomized trial. Clinics (Sao Paulo). 2024 May 20;79:100370. doi: 10.1016/j.clinsp.2024.100370. eCollection 2024.
PubMed 38772100
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Test the Hypothesis That a Support Bra Will Improve Healing and Quality of Life After Coronary Artery By-Pass Graft (CABG)
- ClinicalTrials.gov ID
- NCT02864186
- Acronym / sponsor ID
- SDC4123/14/103
- Conditions
- Quality of Life, Wound Complications, Pain
- Keywords
- Pain, Quality of life, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
That study have the primary purpose identify if exist difference to the healing and quality of life between women that use of a surgical support bra, common support bra and without support bra after coronary artery bypass graft surgery.
To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality of life life through specific instruments.
Detailed description
The patients will be randomized and share into three groups: women after coronary artery bypass surgery use surgical support bra, women after coronary artery bypass surgery use common support bra and those who will not use any support bra.
They will be can tracked and invited to participate in the study few days before the surgery or during the post operatory (2 - 6 days after surgery). The assessement and the intervention must be start in the inpatient unit from the 2nd to 6th post operatory until their discharge.
Initially, it will be apply a questionnaire of quality of life (SF36) to assess the quality of life before the surgical procedure. In this moment, will be measured for breast size and also wil be identify the risk factors through a brief historical.
During the stay in the hospital, the patients will be assessed on a daily basis with respect to the following: pain (verbal numerical scale) and wound appearance.
The questionnaire of quality of life(SF36) will be applied again for more three times, about one month, two months and six months after the discharge together with the assessement to the pain and wound healing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Device: controlWomen wont use support bra for six months |
| surgical support bra | Active comparator | Device: surgical support braWomen will use surgical support bra 24 hours a day for six months |
| common support bra | Active comparator | Device: common support braWomen will use common support bra 24 hours a day for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who undergoing coronary artery bypass graft surgery
- Women who signed the term consent and informed
Key exclusion criteria (3 listed)
- Women who have had any breast surgery
- Women who undergoing radiotherapy to the thorax.
- Women with cognitive impairments.
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 |
|---|---|---|
| controlWomen wont use support bra 24 hours a days for six months | Device | control |
| surgical support braWomen will use surgical support bra 24 hours a day for six months | Device | surgical support bra |
| common support braWomen will use common support bra 24 hours a day for six months | Device | common support bra |
Primary outcome
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
Time frame: at six months after surgery
3 secondary outcomes
Quality of Life pre cardiac surgery - SF36
Time frame: one day before surgery and then at one, two and six months
Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records
Time frame: at six months after surgery
Use of antibiotics and painkillers - Medical Prescription
Time frame: at six months after surgery.
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 2 Mar 2021.
- Derived from this study: PubMed 38772100Silva TRA, Ono JN, Miname FCBR, Gowdak LHW, Mioto BM, Santos RBD, Dallan LRP, Machado Cesar LA. Benefits of using a support bra in women undergoing coronary artery bypass graft surgery: A randomized trial. Clinics (Sao Paulo). 2024 May 20;79:100370. doi: 10.1016/j.clinsp.2024.100370. eCollection 2024.
- 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.
LUIZ AM CESAR, MD, PhD principal investigator
INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical support bra and common support bra in people with Quality of Life and Wound Complications, run by University of Sao Paulo 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 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: finished, as of the sponsor's last update on 2 Mar 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?
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical (time frame: at six months after surgery). 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 NCT02864186, 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 2 Mar 2021.