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

Primary Purpose

Cardiac Surgical Procedures, Wound Healing

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Use of breast bra
Usual care (not use of bra)
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Surgical Procedures focused on measuring Cardiovascular nursing, Bra, Dehiscence, Sternotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Use of breast bra

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Full Information

First Posted
December 3, 2019
Last Updated
February 27, 2020
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol
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1. Study Identification

Unique Protocol Identification Number
NCT04290260
Brief Title
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgical Procedures, Wound Healing
Keywords
Cardiovascular nursing, Bra, Dehiscence, Sternotomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of breast bra
Arm Type
Experimental
Arm Description
Patients allocated on this group wear a breast bra from admission to hospital discharge.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care: participants will not wear a breast bra until discharge from the hospital
Intervention Type
Other
Intervention Name(s)
Use of breast bra
Intervention Description
Patients will use a breast from admission to hospital discharge
Intervention Type
Other
Intervention Name(s)
Usual care (not use of bra)
Primary Outcome Measure Information:
Title
Dehiscence
Description
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".
Time Frame
Baseline (admission) to 6 months after hospital discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violeta Díaz Herrera, RN
Organizational Affiliation
Germans Trias i Pujol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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