Steri-strips for Reducing Radial Artery Compression Duration

NCT04900987 | Completed DMC FDA Device

• 1 other identifier: ERC-29/2021
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Radial artery; TR Band; Steri-strips; Coronary angiogram; Radial patency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Participants with

  Immediately after removal of TR band

• Number of Participants with

  Immediately after removal of TR band

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Steri-strips DEVICE

Pneumatic TR band compression with use of steri-strips

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary angiography through transradial approach
• Either gender with age ≥18 years
• Positive Barbeau test (type A to C)

You may not qualify if:

• Patients refuse to give consent
• Negative Barbeau test (type D)
• Patients with bleeding diathesis or on oral anticoagulation

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 27308241 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)