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Completed

NCT Number: NCT04900987

Steri-strips for Reducing Radial Artery Compression Duration

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steri-strips

Device

Pneumatic TR band compression with use of steri-strips

Primary outcomes

  1. Mean of

    Time frame: Immediately after removal of TR band

    Time duration of achieving hemostasis

  2. Number of Participants with

    Time frame: After 24 hour of removal of TR band

    Radial artery patency

Secondary outcomes

  1. Number of Participants with

    Time frame: Immediately after removal of TR band

    Hematoma

  2. Number of Participants with

    Time frame: Immediately after removal of TR band

    Bleeding

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Registry information

Official study 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

Acronym: RACC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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