NCT04290260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

December 3, 2019

Last Update Submit

February 27, 2020

Conditions

Cardiac Surgical ProceduresWound Healing

Keywords

Cardiovascular nursingBraDehiscenceSternotomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Use of breast bra

EXPERIMENTAL

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

Other: Use of breast bra

Usual care

ACTIVE COMPARATOR

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

Other: Usual care (not use of bra)

Interventions

Use of breast braOTHER

Patients will use a breast from admission to hospital discharge

Use of breast bra
Usual care (not use of bra)OTHER
Usual care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years
  • Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
  • Surgical intervention performed throughout medium sternotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Study Officials

  • Violeta Díaz Herrera, RN

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

February 28, 2020

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)