Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery (DEHISCENCIA)

February 27, 2020 updated by: Germans Trias i Pujol Hospital

Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery

The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.

Aim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.

Methods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Over 18 years
  • Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
  • Surgical intervention performed throughout medium sternotomy

Exclusion Criteria:

  • More than 72 hours admitted in an intensive care unit after surgery
  • Cognitive impairment or severe physical disability
  • Mastectomy
  • External wound occlusion with Opsite® fixative absorbent dressing
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Use of breast bra
Patients allocated on this group wear a breast bra from admission to hospital discharge.
Other: Use of breast bra
Patients will use a breast from admission to hospital discharge
ACTIVE_COMPARATOR: Usual care
Usual care: participants will not wear a breast bra until discharge from the hospital
Other: Usual care (not use of bra)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dehiscence
Time Frame: Baseline (admission) to 6 months after hospital discharge
Dehiscence in the surgical wound. Criteria defined according to an established scale for the assessment of surgical wounds contemplated in the GacelaCare® computer system used in Germans Trias i Pujol University Hospital. Values may be "Yes" or "No".
Baseline (admission) to 6 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Fundació Institut Germans Trias i Pujol

Investigators

  • Principal Investigator: Violeta Díaz Herrera, RN, Germans Trias i Pujol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

February 27, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-14-060
  • PR-1850/14 (OTHER_GRANT: Col·legi Oficial d'Infermeres i Infermers de Barcelona)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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