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Completed

NCT Number: NCT02864186

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Device

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

surgical support bra

Device

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

common support bra

Device

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

Primary outcomes

  1. Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical

    Time frame: at six months after surgery

Secondary outcomes

  1. Quality of Life pre cardiac surgery - SF36

    Time frame: one day before surgery and then at one, two and six months

  2. Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records

    Time frame: at six months after surgery

  3. Use of antibiotics and painkillers - Medical Prescription

    Time frame: at six months after surgery.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2016
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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