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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Dehiscence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Dehiscence
Time Frame: 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".
Secondary Outcomes
No secondary outcomes reported