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

University of Sao Paulo

Status: Completed

Conditions: Quality of Life; Wound Complications; Pain

Treatments: Device: control; Device: common support bra; Device: surgical support bra

Study type: Interventional

Funder types: Other

Identifiers

NCT02864186

SDC4123/14/103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

190 participants in 3 patient groups

control

Active Comparator group

Description:

Women wont use support bra for six months

Treatment:

Device: control

surgical support bra

Active Comparator group

Description:

Women will use surgical support bra 24 hours a day for six months

Treatment:

Device: surgical support bra

common support bra

Active Comparator group

Description:

Women will use common support bra 24 hours a day for six months

Treatment:

Device: common support bra