Steri-strips for Reducing Radial Artery Compression Duration

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Steri-strips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary angiography through transradial approach Either gender with age ≥18 years Positive Barbeau test (type A to C) Exclusion Criteria: Patients refuse to give consent Negative Barbeau test (type D) Patients with bleeding diathesis or on oral anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* Pneumatic TR band compression with use of steri-strips<br>|
| No Intervention: Control group<br>Application of pneumatic TR band alone for 4 hours as per usual practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of | Time duration of achieving hemostasis | Immediately after removal of TR band | 
| Number of Participants with | Radial artery patency | After 24 hour of removal of TR band | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with | Hematoma | Immediately after removal of TR band | 
| Number of Participants with | Bleeding | Immediately after removal of TR band | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial artery, TR Band, Steri-strips, Coronary angiogram, Radial patency