Skip to main content
OpenTrials
Completed

NCT Number: NCT04290260

Use of the Bra as Prevention of Sternal Wound Dehiscence in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Surgical Procedures Wound Healing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of breast bra

Other

Patients will use a breast from admission to hospital discharge

Usual care (not use of bra)

Other

Primary outcomes

  1. 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".

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundació Institut Germans Trias i Pujol

Registry information

Official study title

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

Acronym: DEHISCENCIA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2020
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.