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

Not Applicable

Completed

• Conditions: Quality of Life; Wound Complications; Pain
• Interventions: Device: control; Device: common support bra; Device: surgical support bra

• Registration Number: NCT02864186
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-26
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

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

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Exclusion Criteria

• Women who have had any breast surgery
• Women who undergoing radiotherapy to the thorax.
• Women with cognitive impairments.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	Women wont use support bra for six months
common support bra	common support bra	Women will use common support bra 24 hours a day for six months
surgical support bra	surgical support bra	Women will use surgical support bra 24 hours a day for six months

Primary Outcome Measures

Name	Time	Method
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical	at six months after surgery

Secondary Outcome Measures

Name	Time	Method
Quality of Life pre cardiac surgery - SF36	one day before surgery and then at one, two and six months
Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records	at six months after surgery
Use of antibiotics and painkillers - Medical Prescription	at six months after surgery.

Trial Locations

Locations (1)

Heart Institute (InCor), Univ. of Sao Paulo Medical School; 🇧🇷 Sao Paulo, Brazil