An interventional study of control and surgical support bra in Quality of Life, Wound Complications and Pain, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention
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.
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.
University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women wont use support bra for six months
Device: control
Women will use surgical support bra 24 hours a day for six months
Device: surgical support bra
Women will use common support bra 24 hours a day for six months
Device: common support bra
Women wont use support bra 24 hours a days for six months
Women will use surgical support bra 24 hours a day for six months
Women will use common support bra 24 hours a day for six months
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
Time frame: at six months after surgery
Quality of Life pre cardiac surgery - SF36
Time frame: 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
Use of antibiotics and painkillers - Medical Prescription
Time frame: at six months after surgery.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo