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

Sponsor

Germans Trias i Pujol Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04290260

Collaborator

Fundació Institut Germans Trias i Pujol (Other)

100

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgical Procedures Wound Healing	Other: Use of breast bra Other: Usual care (not use of bra)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Use of breast bra Patients allocated on this group wear a breast bra from admission to hospital discharge.	Other: Use of breast bra Patients will use a breast from admission to hospital discharge
Active Comparator: Usual care Usual care: participants will not wear a breast bra until discharge from the hospital	Other: Usual care (not use of bra)

Arm

Intervention/Treatment

Experimental: Use of breast bra

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

Other: Use of breast bra

Patients will use a breast from admission to hospital discharge

Active Comparator: Usual care

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

Other: Usual care (not use of bra)

Outcome Measures

Primary Outcome Measures

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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916

Sponsors and Collaborators

Germans Trias i Pujol Hospital
Fundació Institut Germans Trias i Pujol

Investigators

Principal Investigator: Violeta Díaz Herrera, RN, Germans Trias i Pujol University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Germans Trias i Pujol Hospital

ClinicalTrials.gov Identifier:

NCT04290260

Other Study ID Numbers:

AC-14-060
PR-1850/14

First Posted:

Feb 28, 2020

Last Update Posted:

Feb 28, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Germans Trias i Pujol Hospital

Cardiovascular nursing

Bra

Dehiscence

Sternotomy

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Feb 28, 2020