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

Wound Healing Clinical Trial

— DEHISCENCIA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290260
• Other study ID #: AC-14-060
• Secondary ID: PR-1850/14
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2020
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Wound Healing
• Wounds and Injuries

Intervention

Other:
• Use of breast bra
Patients will use a breast from admission to hospital discharge
• Usual care (not use of bra)

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundació Institut Germans Trias i Pujol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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