NCT02864186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.6 years

First QC Date

July 18, 2016

Last Update Submit

February 25, 2021

Conditions

Quality of LifeWound ComplicationsPain

Keywords

PainQuality of lifewound healing

Outcome Measures

Primary Outcomes (1)

  • Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical

    at six months after surgery

Secondary Outcomes (3)

  • 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.

Study Arms (3)

control

ACTIVE COMPARATOR

Women wont use support bra for six months

Device: control

surgical support bra

ACTIVE COMPARATOR

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

Device: surgical support bra

common support bra

ACTIVE COMPARATOR

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

Device: common support bra

Interventions

controlDEVICE

Women wont use support bra 24 hours a days for six months

control
surgical support braDEVICE

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

surgical support bra
common support braDEVICE

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

common support bra

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who undergoing coronary artery bypass graft surgery
  • Women who signed the term consent and informed

You may not qualify if:

  • Women who have had any breast surgery
  • Women who undergoing radiotherapy to the thorax.
  • Women with cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor), Univ. of Sao Paulo Medical School

São Paulo, 05403000, Brazil

Location

Related Publications (1)

  • Silva TRA, Ono JN, Miname FCBR, Gowdak LHW, Mioto BM, Santos RBD, Dallan LRP, Machado Cesar LA. Benefits of using a support bra in women undergoing coronary artery bypass graft surgery: A randomized trial. Clinics (Sao Paulo). 2024 May 20;79:100370. doi: 10.1016/j.clinsp.2024.100370. eCollection 2024.

    PMID: 38772100DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • LUIZ AM CESAR, MD, PhD

    INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of Cardiology

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 11, 2016

Study Start

January 26, 2015

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)