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

NCT ID: NCT04290260

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Surgical Procedures Wound Healing

Keywords

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Cardiovascular nursing Bra Dehiscence Sternotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Use of breast bra

Patients allocated on this group wear a breast bra from admission to hospital discharge.

Group Type EXPERIMENTAL

Use of breast bra

Intervention Type OTHER

Patients will use a breast from admission to hospital discharge

Usual care

Usual care: participants will not wear a breast bra until discharge from the hospital

Group Type ACTIVE_COMPARATOR

Usual care (not use of bra)

Intervention Type OTHER

Interventions

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Use of breast bra

Patients will use a breast from admission to hospital discharge

Intervention Type OTHER

Usual care (not use of bra)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Violeta Díaz Herrera, RN

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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PR-1850/14

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AC-14-060

Identifier Type: -

Identifier Source: org_study_id