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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02864186
Enrollment
190
Registered
2016-08-11
Start date
2015-01-26
Completion date
2018-08-30
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Quality of Life, Wound Complications

Keywords

Pain, Quality of life, wound healing

Brief 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. 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.

Interventions

DEVICEcontrol

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

DEVICEsurgical support bra

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

DEVICEcommon support bra

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medicalat six months after surgery

Secondary

MeasureTime frame
Quality of Life pre cardiac surgery - SF36one day before surgery and then at one, two and six months
Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Recordsat six months after surgery
Use of antibiotics and painkillers - Medical Prescriptionat six months after surgery.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026