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

G

Germans Trias i Pujol Hospital

Status

Completed

Conditions

Wound Healing
Cardiac Surgical Procedures

Treatments

Other: Use of breast bra
Other: Usual care (not use of bra)

Study type

Interventional

Funder types

Other

Identifiers

NCT04290260
AC-14-060
PR-1850/14 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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