The Benefits of the Use of a Support Bra in Women Undergoing Coronary Artery By-Pass Graft Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical [at six months after surgery]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Institute (InCor), Univ. of Sao Paulo Medical School | Sao Paulo | Brazil | 05403000 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- SDC4123/14/103