Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900987
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2021-05-20
Brief Title:
Steri-strips for Reducing Radial Artery Compression Duration
Sponsor:
National Institute of Cardiovascular Diseases Pakistan
Organization:
National Institute of Cardiovascular Diseases Pakistan
Study Overview
Official Title:
Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band An Open-label Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
RACC
Brief Summary:
The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis Consequently the frequency of radial artery occlusion RAO will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration
Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method In a study conducted by Faravash et al in 2016 showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid malar and cheek soft tissues with use of steri-strips with no reported safety concerns
Therefore the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression
Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method In a study conducted by Faravash et al in 2016 showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid malar and cheek soft tissues with use of steri-strips with no reported safety concerns
Therefore the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression
Detailed Description:
Study population patients undergoing coronary angiography through transradial approach Study groups patients will be randomly assigned in a 11 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips
Treatment group Pneumatic TR band compression with use of steri-strips
Control group Pneumatic TR band compression alone
Method of radial artery compression after sheath removal
Conventional mechanical compression Application of pneumatic TR band alone for 4 hours
Mechanical compression with use of steri-strips After putting adequate manual pressure proximal to radial puncture site dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour
END POINTS
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Treatment group Pneumatic TR band compression with use of steri-strips
Control group Pneumatic TR band compression alone
Method of radial artery compression after sheath removal
Conventional mechanical compression Application of pneumatic TR band alone for 4 hours
Mechanical compression with use of steri-strips After putting adequate manual pressure proximal to radial puncture site dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour
END POINTS
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None