An interventional study of Steri-strips in Acute Coronary Syndrome, sponsored by National Institute of Cardiovascular Diseases, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Not applicable, Interventional, and Prevention
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.
Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 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
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's enrollment of 204 is close to the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.
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Exclusion Criteria:
After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour.
Device: Steri-strips
Application of pneumatic TR band alone for 4 hours as per usual practice
Pneumatic TR band compression with use of steri-strips
Mean of
Time duration of achieving hemostasis
Time frame: Immediately after removal of TR band
Number of Participants with
Radial artery patency
Time frame: After 24 hour of removal of TR band
Number of Participants with
Hematoma
Time frame: Immediately after removal of TR band
Number of Participants with
Bleeding
Time frame: Immediately after removal of TR band
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Cardiovascular Diseases, Pakistan