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

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864186
• Other study ID #: SDC4123/14/103
• Status: Completed
• Phase: N/A
• Start date: January 26, 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: February 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Quality of Life
• Wound Complications

Intervention

Device:
• control
Women wont use support bra 24 hours a days for six months
• surgical support bra
Women will use surgical support bra 24 hours a day for six months
• common support bra
Women will use common support bra 24 hours a day for six months

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor), Univ. of Sao Paulo Medical School	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical		at six months after surgery
Secondary	Quality of Life pre cardiac surgery - SF36		one day before surgery and then at one, two and six months
Secondary	Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records		at six months after surgery
Secondary	Use of antibiotics and painkillers - Medical Prescription		at six months after surgery.