Steri-strips for Reducing Radial Artery Compression Duration

NCT ID: NCT04900987

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-31

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

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

Steri-strips

Intervention Type: DEVICE

Pneumatic TR band compression with use of steri-strips

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Steri-strips

Pneumatic TR band compression with use of steri-strips

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Kamran Ahmed Khan

Assistant Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 27308241 (View on PubMed)

Other Identifiers

ERC-29/2021

Identifier Type: -

Identifier Source: org_study_id