The Benefits of the Use of a Support Bra in Women Undergoing Coronary Artery By-Pass Graft Surgery

NCT ID: NCT02864186

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-26

Study Completion Date

2018-08-30

Brief Summary

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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

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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

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Quality of Life Wound Complications Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

Women wont use support bra for six months

Group Type ACTIVE_COMPARATOR

control

Intervention Type DEVICE

Women wont use support bra 24 hours a days for six months

surgical support bra

Women will use surgical support bra 24 hours a day for six months

Group Type ACTIVE_COMPARATOR

surgical support bra

Intervention Type DEVICE

Women will use surgical support bra 24 hours a day for six months

common support bra

Women will use common support bra 24 hours a day for six months

Group Type ACTIVE_COMPARATOR

common support bra

Intervention Type DEVICE

Women will use common support bra 24 hours a day for six months

Interventions

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control

Women wont use support bra 24 hours a days for six months

Intervention Type DEVICE

surgical support bra

Women will use surgical support bra 24 hours a day for six months

Intervention Type DEVICE

common support bra

Women will use common support bra 24 hours a day for six months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women who undergoing coronary artery bypass graft surgery
* Women who signed the term consent and informed

Exclusion Criteria

* Women who have had any breast surgery
* Women who undergoing radiotherapy to the thorax.
* Women with cognitive impairments.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luiz Antonio M. Cesar

Associated Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LUIZ AM CESAR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO

Locations

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Heart Institute (InCor), Univ. of Sao Paulo Medical School

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 38772100 (View on PubMed)

Other Identifiers

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SDC4123/14/103

Identifier Type: -

Identifier Source: org_study_id

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