Clinical trial NCT02864186: The Benefits of the Use of a Support Bra in Women Undergoing Coronary Artery By-Pass Graft Surgery
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Wound Complications
Pain
Keywords: Pain
Quality of life
wound healing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
timeFrame: at six months after surgery
Secondary outcomes:
measure: Quality of Life pre cardiac surgery - SF36
timeFrame: one day before surgery and then at one, two and six months
measure: Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records
timeFrame: at six months after surgery
measure: Use of antibiotics and painkillers - Medical Prescription
timeFrame: at six months after surgery.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor), Univ. of Sao Paulo Medical School
Study officials:
affiliation: INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO
name: LUIZ AM CESAR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: