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

National Institute of Cardiovascular Diseases, Pakistan

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Device: Steri-strips

Study type: Interventional

Funder types: Other

Identifiers

NCT04900987

ERC-29/2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Treatment group

Experimental group

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.

Treatment:

Device: Steri-strips

Control group

No Intervention group

Description:

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