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

NCT ID: NCT04290260

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-11-30

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.

Conditions

Cardiac Surgical Procedures; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Use of breast bra

Patients allocated on this group wear a breast bra from admission to hospital discharge.

Group Type: EXPERIMENTAL

Use of breast bra

Intervention Type: OTHER

Patients will use a breast from admission to hospital discharge

Usual care

Usual care: participants will not wear a breast bra until discharge from the hospital

Group Type: ACTIVE_COMPARATOR

Usual care (not use of bra)

Intervention Type: OTHER

Interventions

Use of breast bra

Patients will use a breast from admission to hospital discharge

Intervention Type: OTHER

Usual care (not use of bra)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Violeta Díaz Herrera, RN

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

PR-1850/14

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AC-14-060

Identifier Type: -

Identifier Source: org_study_id