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

Study Overview
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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.

Official Title
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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

Conditions
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Cardiac Surgical Procedures, Wound Healing

Intervention / Treatment
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* Other: Use of breast bra
* Other: Usual care (not use of bra)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of breast bra<br>Patients allocated on this group wear a breast bra from admission to hospital discharge. | Other: Use of breast bra<br>* Patients will use a breast from admission to hospital discharge<br>|
| Active Comparator: Usual care<br>Usual care: participants will not wear a breast bra until discharge from the hospital | Other: Usual care (not use of bra)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dehiscence | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular nursing, Bra, Dehiscence, Sternotomy