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

February 25, 2021 updated by: Luiz Antonio M. Cesar, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Heart Institute (InCor), Univ. of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Women wont use support bra for six months
Device: control
Women wont use support bra 24 hours a days for six months
Active Comparator: surgical support bra
Women will use surgical support bra 24 hours a day for six months
Device: surgical support bra
Women will use surgical support bra 24 hours a day for six months
Active Comparator: common support bra
Women will use common support bra 24 hours a day for six months
Device: common support bra
Women will use common support bra 24 hours a day for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
Time Frame: at six months after surgery
at six months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life pre cardiac surgery - SF36
Time Frame: one day before surgery and then at one, two and six months
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
at six months after surgery
Use of antibiotics and painkillers - Medical Prescription
Time Frame: at six months after surgery.
at six months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: LUIZ AM CESAR, MD, PhD, INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2015

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDC4123/14/103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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