Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 7:36 PM
Study NCT ID:
NCT04290260
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEHISCENCIA
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PR-1850/14 | OTHER_GRANT | Col·legi Oficial d'Infermeres i Infermers de Barcelona | View |