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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04290260

Acronym

DEHISCENCIA

Enrollment

100

Registered

2020-02-28

Start date

2015-01-31

Completion date

2016-11-30

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures, Wound Healing

Keywords

Cardiovascular nursing, Bra, Dehiscence, Sternotomy

Brief summary

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

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.

Interventions

OTHERUse of breast bra

Patients will use a breast from admission to hospital discharge

OTHERUsual care (not use of bra)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Dehiscence	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026