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

Not Applicable

Completed

• Conditions: Cardiac Surgical Procedures; Wound Healing

• Registration Number: NCT04290260
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2019-12-03
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain