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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Quality of Life, Wound Complications, Pain

Intervention / Treatment
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* Device: control
* Device: surgical support bra
* Device: common support bra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Quality of life, wound healing