Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02864186
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Luiz Antonio M. Cesar, University of Sao Paulo

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
Quality of Life Wound Complications Pain Device: control Device: surgical support bra Device: common support bra Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Study Start Date : January 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain - Visual Analog Scale - Medical Documentation or Nursing in the Medical [ Time Frame: at six months after surgery ]

Secondary Outcome Measures :
  1. Quality of Life pre cardiac surgery - SF36 [ Time Frame: one day before surgery and then at one, two and six months ]
  2. Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records [ Time Frame: at six months after surgery ]
  3. Use of antibiotics and painkillers - Medical Prescription [ Time Frame: at six months after surgery. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864186


Contacts
Layout table for location contacts
Contact: LUIZ AM CESAR, MD, PhD +551155354208 luiz.cesar@incor.usp.br
Contact: THAIS RA SILVA, nurse +551126615042 thais.silva@incor.usp.br

Locations
Layout table for location information
Brazil
Heart Institute (InCor), Univ. of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403000
Contact: Luiz AM Cesar, Phd, MD    551126615387    luiz.cesar@incor.usp.br   
Contact: Thais RA Silva, Nurse    5511981386376    thais.silva@incor.usp.br   
Sub-Investigator: Thais RA Silva, Nurse         
Principal Investigator: Luiz AM Cesar, MD, PhD         
Sub-Investigator: Julia N Ono, Nurse         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Principal Investigator: LUIZ AM CESAR, MD, PhD INSTITUTO DO CORAÇÃO, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO

Layout table for additonal information
Responsible Party: Luiz Antonio M. Cesar, Associated Professor of Cardiology, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02864186     History of Changes
Other Study ID Numbers: SDC4123/14/103
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Luiz Antonio M. Cesar, University of Sao Paulo:
Pain
Quality of life
wound healing