Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04290260
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2019-12-03
Brief Title:
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PR-185014 | OTHER_GRANT | Collegi Oficial dInfermeres i Infermers de Barcelona | None |