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Steri-strips for Reducing Radial Artery Compression Duration (RACC)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Steri-strips
Sponsored by
National Institute of Cardiovascular Diseases, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Radial artery, TR Band, Steri-strips, Coronary angiogram, Radial patency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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.

Application of pneumatic TR band alone for 4 hours as per usual practice

Outcomes

Primary Outcome Measures

Mean of
Time duration of achieving hemostasis
Number of Participants with
Radial artery patency

Secondary Outcome Measures

Number of Participants with
Hematoma
Number of Participants with
Bleeding

Full Information

First Posted
May 20, 2021
Last Updated
February 1, 2022
Sponsor
National Institute of Cardiovascular Diseases, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT04900987
Brief Title
Steri-strips for Reducing Radial Artery Compression Duration
Acronym
RACC
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiovascular Diseases, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Radial artery, TR Band, Steri-strips, Coronary angiogram, Radial patency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Application of pneumatic TR band alone for 4 hours as per usual practice
Intervention Type
Device
Intervention Name(s)
Steri-strips
Intervention Description
Pneumatic TR band compression with use of steri-strips
Primary Outcome Measure Information:
Title
Mean of
Description
Time duration of achieving hemostasis
Time Frame
Immediately after removal of TR band
Title
Number of Participants with
Description
Radial artery patency
Time Frame
After 24 hour of removal of TR band
Secondary Outcome Measure Information:
Title
Number of Participants with
Description
Hematoma
Time Frame
Immediately after removal of TR band
Title
Number of Participants with
Description
Bleeding
Time Frame
Immediately after removal of TR band

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Institute of Cardiovascular Diseases
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27308241
Citation
Farahvash MR, Khorasani G, Mahdiani Y, Taheri AR. The Effect of Steri-Strip Dressing on Patients' Satisfaction and Reduction of Ecchymosis in Lower Eyelid, Malar and Cheek Following Rhinoplasty. World J Plast Surg. 2016 Jan;5(1):51-7.
Results Reference
result

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Steri-strips for Reducing Radial Artery Compression Duration

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